Mapping Your Success 2013 BSI Healthcare Roadshow: Mobile Health Software, Mobile Phones and Telemedicine Under the EU Approach
|
|
- Magnus Wilkinson
- 5 years ago
- Views:
Transcription
1 Mapping Your Success 2013 BSI Healthcare Roadshow: Mobile Health Software, Mobile Phones and Telemedicine Under the EU Approach
2 Telemedicine & mhealth Definition of Telemedicine: Use of telecommunication and information technologies in order to provide clinical health care at a distance. (Source: Definition of mobile health (mhealth): Practice of medicine and public health, supported by mobile devices. The term is most commonly used in reference to using mobile communication devices, such as mobile phones, tablet computers and PDAs, for health services and information mhealth applications include the use of mobile devices in collecting community and clinical health data, delivery of healthcare information to practitioners, researchers, and patients, real-time monitoring of patient vital signs, and direct provision of care (via mobile telemedicine). (Source: When are mobile and other telemedicine devices and their software applications considered to be medical devices? 2
3 Directives, Standards, & Guidance Documents Directives - Mandatory Harmonized Standards* Non-harmonized Standards** Guidance Documents*** 93/42/EEC (MDD) 90/385/EEC (AIMDD) 98/79/EC (IVDD) EN ISO EN ISO EN IEC EN EN ISO/IEC EN IEC MEDDEV 2.1/6 IEC/TR NB-MED/ 2.2/Rec4 * Harmonized standards provide a presumption of conformity with the essential requirements of the directives. ** Use of non-harmonized standards can help provide compliance with directives. *** Guidance documents are agreed upon (by Competent Authorities, Notified Bodies, Industry, etc.) directive interpretations and if followed, ensure uniform application of relevant directive provisions Legally not binding 3
4 European Harmonized Standards Standard EN Topic Medical device SW SW lifecycle processes EN ISO Medical devices - Quality management systems Requirements for regulatory purposes EN ISO EN Medical devices Application of risk management to medical devices (Note: Normative reference in EN 62304) Medical electrical equipment General requirements for basic safety and essential performance Section 14: Programmable electrical medical systems (PEMS) (Note: Not harmonized to IVD Directive) EN Application of usability engineering to medical devices 4
5 International Guidance Guidance MEDDEV 2.1/6 (2012) IEC/TR :2009 Topic Guidelines for the qualification and classification of standalone SW used within healthcare within the regulatory framework of medical devices Medical device SW - Part 1: Guidance on the application of ISO to medical device SW NB-MED/2.2/Rec4 SW and Medical Devices (2001) Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices Picture Archiving and Communication Systems (PACS) is included 5
6 MDD 93/42/EEC M5 (2007/47) Changes 1. Article 1: Change of Definition of Medical device - medical device means any instrument, apparatus, appliance, software, material or other article 2. New sub-clause ER 12.1a: For devices which incorporate software or which are medical software in themselves, the software must be validated according to the state of the art taking into account the principles of development lifecycle, risk management, validation and verification. 3. Annex IX Active Medical Device definition in the classification criteria added Stand alone software is considered to be an active medical device. 6
7 Definition of Accessory An article which whilst not being a device is intended specifically by its manufacturer to be used together with a device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device. 7
8 Medical Device Classification Directive Classification Accessory AIMD Directive All AIMDs are one classification (considered high risk) All AIMD accessories are given same high risk classification MD Directive Rule-based Accessories are classified in their own right IVD Directive List, not rule-based (List A - high -or- List B - moderate risk devices) Accessories are classified in their own right * If SW is embedded in a medical device, it takes on the classification of the medical device * 8
9 Classification of stand alone software (Annex IX 93/42/EEC) Definition: Stand alone software is an active device Non invasive devices Invasive devices Additional rules applicable to active devices Special rules Rules 1 to 4 Rules 5 to 8 Rule 9 Rule 10 Rule 11 Rule 12 Rules 13 to 18 Applicable active device rules 9
10 Classification of stand alone SW(Annex IX) Rule # Summary Classification 9 All active therapeutic devices intended to administer or exchange energy 10 Active devices intended for diagnosis 11 Active devices to administer or remove medicines, body liquids, or other substances 12 All other Active Devices ( fall through rule) Class IIa unless potentially hazardous way then Class IIb Class IIa or Class IIb (e.g. ionizing radiation) Class IIa unless potentially hazardous way then Class IIb Class I Annex IX, 2.3: SW which drives a device or influences the use of a device, falls automatically in the same device class. 10
11 MEDDEV 2.1/6 GUIDELINES ON THE QUALIFICATION AND CLASSIFICATION OF STAND ALONE SOFTWARE USED IN HEALTHCARE WITHIN THE REGULATORY FRAMEWORK OF MEDICAL DEVICES 2013 Medical Device Roadshow 11
12 Scope of MEDDEV 2.1/6 Scope is stand alone software (no embedded software) Defines criteria for software being a stand alone medical device (qualification criteria) Potential risk arising from the use of stand alone software is not enough to qualify the software as a medical device Explains application of classification rules for stand alone software 12
13 Software is a medical device if (A) Software is a computer program (B) Software is not incorporated in a medical device (C) Software action is more than basic data processing (D) Software has benefit for individuals (E) Intended purpose is acc. to MDD or software is an accessory acc. to MDD s definition Software falls under MDD regulations 13
14 MEDDEV 2.1/6: Criterion (A) Software is a computer program IF c b DO i WHILE IF f g a k A computer program is defined as syntactic unit that conforms to the rules of a particular programming language and that is composed of declarations and statements or instructions needed to solve a certain function, task, or problem. ENDIF d h Definition Source: ISO/IEC :1993 Information technology Vocabulary -- Part 1: Fundamental terms. ENDIF e 14
15 MEDDEV 2.1/6: Criterion (A) Software is a computer program Not a medical device: DICOM files ECG recordings Data in electronic patient record 15
16 MEDDEV 2.1/6: Criterion (B) Software is not part of a medical device Software as integral part of a medical device Not a device on its own Software program used with general purpose hardware 16
17 MEDDEV 2.1/6: Criterion (C) Software action more than basic data processing more than Storing, archiving, lossless compression 17
18 Criterion (C) Software performance more than basic data processing more than Data transfer (communication) Location A Location B Presentation of information for embellishment purposes Before After 18
19 MEDDEV 2.1/6: Criterion (C) Software performance more than basic data more than Performing simple search Examples of simple search : Searching for blood glucose values measured within January 2012 Number of digital X-ray images which were taken within March 2012 Simple Search excludes: Generation of medical relevant information (search results that help with interpretation or perception) 19
20 MEDDEV 2.1/6: Criterion (D) Benefit for individuals Not a medical device: - Software which processes population data for scientific purposes - Digitized medical literature Patient Benefit Anonymized Test Population 20
21 MEDDEV 2.1/6: Criterion (E) Purpose of the software is medical Medical intended purpose according to 93/42/EEC MEDDEV 2.1/6: If the manufacturer specifically intends the software to be used for any of the purposes listed in Article 1(2)a of Directive 93/42/EEC, then the software shall be qualified as a medical device. We have learned: Software is not a medical device if: only basic data processing is performed Software is a medical device if: intended use (as defined by manufacturer) is medical 21
22 MEDDEV 2.1/6: Criterion (E) Purpose of the software is medical Software might be qualified as a medical device (i.e. have a medical purpose) if it does any of the following to medical information: Create medical information Modify medical information Facilitate perception of medical information Facilitate interpretation of medical information 22
23 Example: Software as accessory according to the MDD Rainer Sturm / Monitoring/controling infusion pump 23
24 What is the Medical Device? Is it a medical device or an accessory to a medical device? Using 3 rd party devices which are already CE marked? Software on the web, PC, tablet, mobile phone? Home Repository Care Provider 24
Regulatory Aspects of Digital Healthcare Solutions
Regulatory Aspects of Digital Healthcare Solutions TÜV SÜD Product Service GmbH Dr. Markus Siebert Rev. 02 / 2017 02.05.2017 TÜV SÜD Product Service GmbH Slide 1 Contents Digital solutions as Medical Device
More informationMed-Info. Council Directive 93/42/EEC on medical devices. TÜV SÜD Product Service GmbH
Med-Info International expert information for the medical device industry Council Directive 93/42/E on medical devices Practice-oriented summary of the most important aspects and requirements contained
More informationMed-Info. Council Directive 93/42/EEC on medical devices. TÜV SÜD Product Service GmbH
Med-Info International expert information for the medical device industry Council Directive 93/42/E on medical devices Practice-oriented summary of the most important aspects and requirements contained
More informationMed-Info. Council Directive 93/42/EEC on Medical Devices. TÜV SÜD Product Service GmbH
Med-Info International expert information for the Medical Device industry Council Directive 93/42/E on Medical Devices Practice-oriented summary of the most important aspects and requirements contained
More informationRequirements on clinical data in Europe
Requirements on clinical data in Europe Dr. Bassil Akra Director Global Clinical Affairs TÜV SÜD Product Service Current Medical Device Directives Applicable Directives Active Implantable Medical Devices
More informationklinischen Datenanforderungen in Europa: Ist die Literaturroute noch möglich?
Regulatorische Änderungen bei den klinischen Datenanforderungen in Europa: Ist die Literaturroute noch möglich? Hamburg, 30.09.2015 Dr. Bassil Akra Director Clinical Centre of Excellence TÜV SÜD Product
More information!"# $ # # $ $ % $ &% $ '"# $ ()&*&)+(( )+(( )
!"# # # % &% '"# ) !#, ' "# " "# -. / # 0 0 0 0 0 "0 "# " # 1 #! " " 0 0 0 0 0 0 2# 0 # # 3 ' 4 56 7-56 87 9# 5 6 7 6 & 0 " : 9 ; 4 " #! 0 - '% # % "# " "# " < 4 "! % " % 4 % % 9# 4 56 87 = 4 > 0 " %!#
More informationContent of mandatory certificates
Chapter: 2.5.1 Conformity assessment procedures; General rules Text:... Key words: certificate, certificate of competence, 1. Purpose The purpose of this recommendation is to provide guidance on the minimum
More informationIVDR Breakout. Copyright 2017 BSI. All rights reserved.
IVDR Breakout 1 IVDR Classification and conformity assessment 2 Classification- IVDR 3 Classification of IVDs Re-classification of IVDs will mean 80-90 % will no longer be able to self certify conformity
More informationMedical Device Usability
Medical Device Usability David Adams Global Head, Active Medical Devices Add logo on slide 4 here Topics What is usability? Why usability is so important The regulatory requirements EN 62366 Usability
More informationClassification and regulation of software
Classification and regulation of software Ciara Farrell, Arthur Cox 5 October 2017 Medtec Ireland 2017 2 Law cannot keep up! 3 Legal issues Regulation as medical devices Privacy and cybersecurity Licensing
More informationSundhedsappsfra innovation til kommercialisering
Sundhedsappsfra innovation til kommercialisering App Certificering Brian Hedegaard, DELTA Apps Hot as ever 2014 ~ 97.000 2015 ~ 165.000! 50.000 2012 - ~ 40% medical device or likely to be! 82% downloaded
More informationWEBINAR on the new Medical Device Regulation One-stop testing, inspection, certification and training solutions. TÜV SÜD Product Service
WEBINAR on the new Medical Device Regulation 2017-07-12 One-stop testing, inspection, certification and training solutions TÜV SÜD Product Service TÜV SÜD at a glance 150+ YEARS OF QUALITY, SAFETY & SUSTAINABILITY
More informationSeminar om de nye regler for certificering
Seminar om de nye regler for certificering Certificeringer af sundheds-apps Susie Wagner Bondorf Partner og med-stifter Background ehealth Action Plan 2012-2020 üa Green Paper on mobile health (mhealth)
More informationVoluntary certification at an intermediate stage of manufacture
Chapter: 2.15 Other Text: Key words: MDD results of any assessment and verification operation, which where appropriate have been carried out in accordance with this Directive at an intermediate stage of
More informationLNE/G-MED North America, Inc
LNE/G-MED North America, Inc Medical Device Usability: Highlights of European Regulations and the Latest Standards Do not distribute or reproduce without permission 1 Sara Jafari, Ph.D., Medical Device
More informationGUIDANCE AND INTERPRETATION DOCUMENTS TO THE REQUIREMENTS FOR THE COMPETENCE OF CONFORMITY ASSESSMENT BODIES
GUIDANCE AND INTERPRETATION DOCUMENTS TO THE REQUIREMENTS FOR THE COMPETENCE OF CONFORMITY ASSESSMENT BODIES Table of Contents 1 PURPOSE... 2 2 GENERAL... 2 3 GUIDANCE AND INTERPRETATIVE DOCUMENTS... 2
More informationUnited4Health session Regulatory Framework Trends & Updates. Nicole Denjoy COCIR Secretary General Wed. 7 May 2014, Berlin (Germany)
United4Health session Regulatory Framework Trends & Updates Nicole Denjoy COCIR Secretary General Wed. 7 May 2014, Berlin (Germany) Outline 1. What is COCIR? 2. COCIR s vision on ehealth 3. Overview on
More informationHow the European Commission is supporting innovation in mobile health technologies Nordic Mobile Healthcare Technology Congress 2015
How the European Commission is supporting innovation in mobile health technologies Nordic Mobile Healthcare Technology Congress 2015 Claudia Prettner, Unit for Health and Well-Being, DG CONNECT Table of
More informationApplying Human Factors to Medical Device Design
Applying Human Factors to Medical Device Design Standards and Guidelines MEDEC 2016 Tim Reeves, PhD CHFP About Tim Reeves Founder and Managing Director of Human Factors MD Inc. Ten- person human factors
More informationNational Accreditation Scheme
National Accreditation Scheme Rules of Procedure on the Preparation of Accreditation Audit Cycle NAR-25 Edition 3 Version 1 Approved by: Csaba Bodroghelyi Deputy Director General Responsible for preparation:
More informationARTICLE 29 DATA PROTECTION WORKING PARTY
ARTICLE 29 DATA PROTECTION WORKING PARTY 18/EN WP261 Article 29 Working Party Draft Guidelines on the accreditation of certification bodies under Regulation (EU) 2016/679 Adopted on 6 february 2018 1 THE
More informationIAF Mandatory Document KNOWLEDGE REQUIREMENTS FOR ACCREDITATION BODY PERSONNEL FOR INFORMATION SECURITY MANAGEMENT SYSTEMS (ISO/IEC 27001)
IAF Mandatory Document KNOWLEDGE REQUIREMENTS FOR ACCREDITATION BODY PERSONNEL FOR INFORMATION SECURITY MANAGEMENT SYSTEMS (ISO/IEC 27001) (IAF MD 13:2015) Issue 1 IAF MD - Knowledge Requirements for Accreditation
More informationETSI TR V1.1.1 ( )
TR 119 400 V1.1.1 (2016-03) TECHNICAL REPORT Electronic Signatures and Infrastructures (ESI); Guidance on the use of standards for trust service providers supporting digital signatures and related services
More informationGuidelines 4/2018 on the accreditation of certification bodies under Article 43 of the General Data Protection Regulation (2016/679)
Guidelines 4/2018 on the accreditation of certification bodies under Article 43 of the General Data Protection Regulation (2016/679) Adopted on 4 December 2018 Adopted 1 Contents 1 Introduction... 3 2
More informationTechnical Report No for the conformity assessment according to the EMC Directive 2004/108/EC
Technical Report for the conformity assessment according to the EMC Directive 2004/108/EC, Article 7 and Annex III or respectively the EMC Law in the currently valid version Client: ABB Automation Products
More informationIn-Vitro Diagnostic Directive (IVDD) and IVDD Technical File Preparation Workshop. 3-4 July 2014 TÜV SÜD
In-Vitro Diagnostic Directive (IVDD) and IVDD Technical File Preparation Workshop 3-4 July 2014 TÜV SÜD Introduction The In-Vitro Diagnostic Directive (IVDD) 98/79/EC applies to all In-Vitro Diagnostic
More informationCOMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) GUIDELINE ON REQUIREMENTS FOR PLASMA MASTER FILE (PMF) CERTIFICATION
The European Agency for the Evaluation of Medicinal Products Evaluation of Medicines for Human Use London, 26 February 2004 COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) GUIDELINE ON REQUIREMENTS
More informationINAB Mandatory and Guidance Documents Policy and Index
INAB Mandatory and Guidance s Policy and Index This publication is aimed at assisting in determining what documents are relevant to various organisations and at providing contact points for accessing such
More informationUDI in the MDR. Economic Operators The new regulations create Economic Operators who play a role in the UDI system.
UDI in the MDR The European Union intends to replace the existing directives related to medical device, Active Implantable Medical Devices, In Vitro Diagnostic Devices, and Medical Devices, with two regulations.
More informationCOMMON REGULATORY OBJECTIVES FOR GSM EQUIPMENT PART 2 SPECIFIC ASPECTS OF GSM EQUIPMENT
COMMON REGULATORY OBJECTIVES FOR GSM EQUIPMENT PART 2 SPECIFIC ASPECTS OF GSM EQUIPMENT 1. SCOPE This Common Regulatory Objective, CRO, is applicable to GSM equipment, as defined in Clause 2. A CRO is
More informationHELP! IS MY M-HEALTH SOFTWARE SUDDENLY A MEDICAL DEVICE? A Challenge of convergence between ehealth, mhealth and Medical Devices
HELP! IS MY M-HEALTH SOFTWARE SUDDENLY A MEDICAL DEVICE? A Challenge of convergence between ehealth, mhealth and Medical Devices A short introduction Hansjörg Riedwyl, CEO Hansjoerg.riedwyl@iss-ag.ch ISS
More informationGuidelines for Interface Publication Issue 3
Editorial Note : These Guidelines are based on the OFTEL Guidelines Issue 2, which provided guidance on interface publication under the R&TTE Directive. They have now been amended to reflect the terminology
More informationETSI European CA DAY TRUST SERVICE PROVIDER (TSP) CONFORMITY ASSESSMENT FRAMEWORK. Presented by Nick Pope, ETSI STF 427 Leader
ETSI European CA DAY TRUST SERVICE PROVIDER (TSP) CONFORMITY ASSESSMENT FRAMEWORK Presented by Nick Pope, ETSI STF 427 Leader ETSI 2012 All rights reserved Topics Background ETSI Activities / Link to Mandate
More informationUDI in Europe. Mr. Salvatore Scalzo, Policy and Legal Officer, Medical Devices, DG GROW, European Commission. 19 October 2017
UDI in Europe Mr. Salvatore Scalzo, Policy and Legal Officer, Medical Devices, DG GROW, European Commission 19 October 2017 The new EU Medical Device Regulations: Introduction to the future EU UDI System
More informationGuidelines 1/2018 on certification and identifying certification criteria in accordance with Articles 42 and 43 of the Regulation 2016/679
Guidelines 1/2018 on certification and identifying certification criteria in accordance with Articles 42 and 43 of the Regulation 2016/679 Adopted on 25 May 2018 Contents 1. Introduction... 2 1.1. Scope
More informationEA-7/05 - EA Guidance on the Application of ISO/IEC 17021:2006 for Combined Audits
Publication Reference EA-7/05 EA Guidance on the Application of ISO/IEC 17021:2006 for Combined Audits PURPOSE This document has been prepared by a task force under the direction of the European Cooperation
More informationCRITERIA FOR CERTIFICATION BODY ACCREDITATION IN THE FIELD OF RISK BASED INSPECTION MANAGEMENT SYSTEMS
CRITERIA FOR CERTIFICATION BODY ACCREDITATION IN THE FIELD OF RISK BASED INSPECTION MANAGEMENT SYSTEMS Approved By: Executive: Accreditation: Mpho Phaloane Revised By: RBI STC Working Group Members Date
More informationMedical Device Documentation Submissions
Medical Device Documentation Submissions Best Practice Guidelines Everything you need to know to successfully submit technical documentation for certification. 1 Contents 1 Introduction 3 2 Submission
More informationMed-Info. Malaysia Medical Device Regulations. TÜV SÜD Product Service GmbH. International expert information for the medical device industry
Med-Info International expert information for the medical device industry Malaysia Medical Device Regulations Passed in 2012, the Medical Device Act (Act 737) and the Medical Device Authority Act 2012
More informationConformity assessment
Training Course on Conformity and Interoperability, Tunis-Tunisia, from 22 to 26 May 2017 Conformity assessment Presented by: Karim Loukil & Kaïs Siala Page 1 Today s Objectives Present basic information
More informationINAB Mandatory and Guidance Documents Policy and Index
INAB Mandatory and Guidance s Policy and Index This publication is aimed at assisting in determining what documents are relevant to various organisations and at providing contact points for accessing such
More informationPRODUCT CERTIFICATION SCHEME FOR METROLOGY SYSTEM
Ref No: RACS/PCS/20 Page 1 of 8 1. Objective: This procedure describes the criteria implemented by RACS as Notified Body of Emirates Authority of Standardization and Metrology (ESMA) that Metrology System
More informationENCePP Code of Conduct Implementation Guidance for Sharing of ENCePP Study Data
EMA/409316/2010 Revision 2, dated 14 July 2016 European Network of Centres for Pharmacoepidemiology and Pharmacovigilance ENCePP Code of Conduct Implementation Guidance for Sharing of ENCePP Study Data
More informationCEN and CENELEC Position Paper on the draft regulation ''Cybersecurity Act''
CEN Identification number in the EC register: 63623305522-13 CENELEC Identification number in the EC register: 58258552517-56 CEN and CENELEC Position Paper on the draft regulation ''Cybersecurity Act''
More informationGUIDE 63. Guide to the development and inclusion of safety aspects in International Standards for medical devices
GUIDE 63 Guide to the development and inclusion of safety aspects in International Standards for medical devices Second edition 2012 ISO/IEC 2012 ISO/IEC GUIDE 63:2012(E) This is a preview - click here
More informationRev 2 May Health and Safety Authority. Function and Scope of REACH and CLP Helpdesk
Rev 2 May 2011 Health and Safety Authority Function and Scope of REACH and CLP Helpdesk Introduction The EU Regulation for Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) entered
More informationGuidance for Requirements for qualified trust service providers: trustworthy systems and products
Guidance for Requirements for qualified trust service providers: trustworthy systems and products Note on using the guidance: examples are used throughout they are not normative or exclusive, but there
More informationehealth action in the EU
ehealth action in the EU ehealth for smart and inclusive growth 13 February 2014 Jerome Boehm DG SANCO ehealth and Health Technology Assessment General Health Objectives of the EU cooperation on ehealth
More informationSPECIFIC PROVISIONS FOR THE ACCREDITATION OF CERTIFICATION BODIES IN THE FIELD OF INFOR- MATION SECURITY MANAGEMENT SYSTEMS (ISO/IEC 27001)
BELAC 2-405-ISMS R0 2017 SPECIFIC PROVISIONS FOR THE ACCREDITATION OF CERTIFICATION BODIES IN THE FIELD OF INFOR- MATION SECURITY MANAGEMENT SYSTEMS (ISO/IEC 27001) The only valid versions of the documents
More informationSPECIFIC PROVISIONS FOR THE ACCREDITATION OF CERTIFICATION BODIES IN THE FIELD OF FOOD SAFETY MANAGEMENT SYSTEMS
BELAC 2-405-FSMS Rev 1-2017 SPECIFIC PROVISIONS FOR THE ACCREDITATION OF CERTIFICATION BODIES IN THE FIELD OF FOOD SAFETY MANAGEMENT SYSTEMS The only valid versions of the documents of the BELAC management
More informationISO/IEC INTERNATIONAL STANDARD
INTERNATIONAL STANDARD ISO/IEC 14143-2 First edition 2002-11-15 Information technology Software measurement Functional size measurement Part 2: Conformity evaluation of software size measurement methods
More informationGUIDELINES ON FEATURES AND TECHNICAL SPECIFICATIONS FOR MOBILE CELLULAR DEVICES IMPORTED INTO AND DISTRIBUTED IN KENYA
GUIDELINES ON FEATURES AND TECHNICAL SPECIFICATIONS FOR MOBILE CELLULAR DEVICES IMPORTED INTO AND DISTRIBUTED IN KENYA June 2018 Table of Contents 1. Scope... 3 2. References... 4 3. Abbreviations and
More informationReport of the Working Group on mhealth Assessment Guidelines February 2016 March 2017
Report of the Working Group on mhealth Assessment Guidelines February 2016 March 2017 1 1 INTRODUCTION 3 2 SUMMARY OF THE PROCESS 3 2.1 WORKING GROUP ACTIVITIES 3 2.2 STAKEHOLDER CONSULTATIONS 5 3 STAKEHOLDERS'
More informationISO TC46/SC11 Archives/records management
ISO TC46/SC11 Archives/records management GUIDANCE FOR IMPLEMENTING DOCUMENTED INFORMATION CLAUSE USING PROCESSES AND CONTROLS OF ISO 30301:2011 Management system for records EXPLANATORY PAPER NOVEMBER
More informationUDI Implementation Update. GS1 UK Healthcare Conference - 22 November 2017 John Wilkinson OBE Medicines and Healthcare Products Regulatory Agency
UDI Implementation Update GS1 UK Healthcare Conference - 22 November 2017 John Wilkinson OBE Medicines and Healthcare Products Regulatory Agency 2 Why new European medical device and IVD regulations? Old
More informationInformation technology Service management. Part 10: Concepts and vocabulary
Provläsningsexemplar / Preview INTERNATIONAL STANDARD ISO/IEC 20000-10 First edition 2018-09 Information technology Service management Part 10: Concepts and vocabulary Technologies de l'information Gestion
More informationGuide to the implementation and auditing of ISMS controls based on ISO/IEC 27001
Guide to the implementation and auditing of ISMS controls based on ISO/IEC 27001 Information Security Management Systems Guidance series The Information Security Management Systems (ISMS) series of books
More informationSummary of Changes in ISO 9001:2008
s in ISO 9001:2008 Clause 0.1 Introduction General Added the phrase its organizational environment, changes in that environment, or risks associated with that environment, to the first paragraph Created
More informationThe upcoming EU MDR. UDI requirements. Gert Bos. Executive director & Partner. ..the practical approach
The upcoming EU MDR UDI requirements Gert Bos Executive director & Partner A global leading medical device consultancy group Europe - Amsterdam (HQ) USA - Boston - San Francisco China Nanjing Copyright
More informationS. Scholz / K. Meyer / J.E. Nielsen / Harald Drück/J.Fernández/E.Prado/L.Nelson Page 1 of 7
Global Solar Certification Network Working Rules Annex A. Requirements for Certification Bodies and their subcontracted laboratories, inspection bodies and inspectors Date: 2017/03/07 Document number:
More informationTesting and Certification Procedure
A PM 101E April 2011 Guideline for the Testing and Certification Procedure of the VDE Testing and Certification Institute (VDE Institute) (For information purpose only. In any case the German version shall
More informationMarks associated with TUV SUD BABT Certification Schemes
TUV SUD BABT is a certification body of TUV SUD BABT 2017 BABT_AP014.docx Page 1 of 11 Contents 1. Introduction... 3 2. Definitions... 3 3. Overview of Schemes and Associated Marks... 3 4. Accreditation
More informationCustomer Interface Publication: KCH CIP018. Technical Characteristics of the Telex Interface
Customer Interface Publication: KCH CIP018 Technical Characteristics of the Telex Interface Issue: 1.1 August 2007 The information in this document is provided in accordance with the requirements of the
More informationData Processing Agreement DPA
Data Processing Agreement DPA between Clinic Org. no. «Controller». and Calpro AS Org. nr. 966 291 281. «Processor» If the parties have executed a Data Management Agreement, the Date Management Agreement
More informationeidas Workshop Return on Experience from Conformity Assessment Bodies - EY June 13, 2016 Contacts: Arvid Vermote
eidas Workshop Return on Experience from Conformity Assessment Bodies - EY June 13, 2016 Contacts: Arvid Vermote arvid.vermote@be.ey.com EY eidas Certification scheme Scheme EY CertifyPoint B.V. is currently
More informationSolutions that ensure safety, reliability and compliance.
RED Transition and Implementation by TÜV SÜD Radu Gosav, Senior Manager EMC&RF, Greater China Solutions that ensure safety, reliability and compliance. TÜV SÜD Greater China Slide 1 17-02-22 1 RED Introduction
More informationENISA s Position on the NIS Directive
ENISA s Position on the NIS Directive 1 Introduction This note briefly summarises ENISA s position on the NIS Directive. It provides the background to the Directive, explains its significance, provides
More informationISO INTERNATIONAL STANDARD
INTERNATIONAL STANDARD ISO 15223-2 First edition 2010-01-15 Medical devices Symbols to be used with medical device labels, labelling, and information to be supplied Part 2: Symbol development, selection
More informationehealth Spare Parts as a Service: Modular ehealth Solutions and Medical Device Reform
brill.com/ejhl ehealth Spare Parts as a Service: Modular ehealth Solutions and Medical Device Reform Nadezhda Purtova Assistant professor, Tilburg Institute for Law, Technology, and Society (TILT), Tilburg
More informationThis document is a preview generated by EVS
INTERNATIONAL STANDARD ISO/IEC 29151 First edition 2017-08 Information technology Security techniques Code of practice for personally identifiable information protection Technologies de l'information Techniques
More informationRegulating Telemedicine: the
Regulating Telemedicine: the EU perspective ETSI ehealth workshop On telemedicine 6-7 May 2014 Céline Deswarte, Policy officer Unit Health and Well-Being European Commission i Table of Contents t 1) Legal
More information21 CFR PART 11 FREQUENTLY ASKED QUESTIONS (FAQS)
21 CFR PART 11 FREQUENTLY ASKED QUESTIONS (S) The United States Food and Drug Administration (FDA) defines the criteria under which electronic records and electronic signatures are considered trustworthy,
More informationCNAS-RC01. Rules for Accreditation of Certification Bodies
CNAS-RC01 Rules for Accreditation of Certification Bodies CNAS CNAS-RC01:2014 Page 1 of 25 Foreword... 2 1 Scope... 3 2 Reference Documents... 3 3 Terms and Definitions... 3 4 General... 5 5 Accreditation
More informationThis document is a preview generated by EVS
INTERNATIONAL STANDARD ISO 17090-1 Second edition 2013-05-01 Health informatics Public key infrastructure Part 1: Overview of digital certificate services Informatique de santé Infrastructure de clé publique
More informationMarks associated with TÜV SÜD BABT Certification Schemes
Marks associated with TÜV SÜD BABT Certification TÜV SÜD BABT is a certification body of TÜV SÜD BABT 2012 Date:23 April 2012 Page 1 of 15 Contents 1. Introduction... 4 2. Definitions... 4 3. Overview
More informationFDA CDRH perspective on new technologies in inhaler products
2017 IPAC RS/ISAM Joint Workshop New Frontiers in Inhalation Technology FDA CDRH perspective on new technologies in inhaler products Linda Ricci Associate Director ODE DH Office of Device Evaluation Center
More informationAn unofficial translation, in case of any discrepancies between the English version and the original Swedish version the latter will prevail.
An unofficial translation, in case of any discrepancies between the English version and the original Swedish version the latter will prevail. Consolidated version of The Swedish Board for Accreditation
More informationGUIDELINE. of the European Committee for Welding of Railway Vehicles (ECWRV) ( ) PART 1
GUIDELINE of the European Committee for Welding of Railway Vehicles (ECWRV) (2016-05-10) PART 1 Procedure for the application of EN 15085 and certification of welding manufacturers for welding railway
More informationECG100S. General Information. Product Code
General Information Product Name General Name Product Code 80508096 Manufacturer Device Description Intended Use Cardioline Spa Registered Office and Factory: Via Linz, 19-20-21 Zona Ind. Spini di Gardolo
More informationTURKISH ACCREDITATION AGENCY. Training, Promotion and Information Directorate
TURKISH ACCREDITATION AGENCY Training, Promotion and Information Directorate About us... Main field of activity of the Training, Promotion and Information Directorate (TPID) is organizing the training
More informationInformation technology Security techniques Code of practice for personally identifiable information protection
INTERNATIONAL STANDARD ISO/IEC 29151 First edition 2017-08 Information technology Security techniques Code of practice for personally identifiable information protection Technologies de l'information Techniques
More informationAccreditation Criteria For Conformity Assessment Bodies
Page 1 of 8 Reviewed by: Getnet Tsigemalak Approved by: Araya Fesseha Position: Quality Manager Position: Director General Signature: Signature: Contents Page 1 Purpose and Scope... 2 2 References... 2
More informationRequirements for Certification Bodies
ISCC PLUS 251 Requirements fo Certification Bodies Requirements for Certification Bodies ISCC PLUS 251 V 1.0 Copyright notice ISCC 2012 This ISCC document is protected by copyright. It is freely available
More informationInformation technology Security techniques Guidance on the integrated implementation of ISO/IEC and ISO/IEC
Provläsningsexemplar / Preview INTERNATIONAL STANDARD ISO/IEC 27013 Second edition 2015-12-01 Information technology Security techniques Guidance on the integrated implementation of ISO/IEC 27001 and ISO/IEC
More information1. STRATEGIC PLANNING
RAC (EU) EXAMINATION SUBJECTS & FORMAT The European RAC Examination is a knowledge-based examination addressing European Union laws, regulations, policies and guidelines affecting medical RAC devices,
More informationGlobal Wind Organisation CRITERIA FOR THE CERTIFICATION BODY
Global Wind Organisation CRITERIA FOR THE CERTIFICATION BODY December 2015 (Version 3) 1 Contents 1. Introduction... 5 2. Criteria for approval of a Certification Body... 5 3. Selection of audit team members
More informationMarks Associated with TUV SUD BABT Certification Schemes
Marks Associated with TUV SUD BABT Certification Schemes TUV SUD BABT is a Certification Body of TUV SUD BABT 2018 BABT AP014 Page 1 of 11 Contents 1. Introduction...3 2. Definitions...3 3. Overview of
More informationAn Update on the Activities and Progress of the mhealth Regulatory Coalition Prepared for the 2011 Medical Device Connectivity Conference
An Update on the Activities and Progress of the mhealth Regulatory Coalition Prepared for the 2011 Medical Device Connectivity Conference Dane Stout The Anson Group September 8, 2011 MRC Background Formed
More informationINTRODUCTION TO THE QUALIFIED COURSE PROFESSIONAL GUIDELINES
INTRODUCTION TO THE QUALIFIED COURSE PROFESSIONAL GUIDELINES As the challenge course industry matures, it becomes more important to designate those who are qualified to deliver services. For this reason,
More informationPart 7: Medication data
INTERNATIONAL STANDARD ISO 21549-7 Second edition 2016-12-01 Health informatics Patient healthcard data Part 7: Medication data Informatique de santé Données relatives aux cartes de santé des patients
More informationThe Accreditation and Verification Regulation - Verification report
EUROPEAN COMMISSION DIRECTORATE-GENERAL CLIMATE ACTION Directorate A - International and Climate Strategy CLIMA.A.3 - Monitoring, Reporting, Verification Guidance Document The Accreditation and Verification
More informationTechnical guidelines implementing eidas
Technical guidelines implementing eidas Sławek Górniak CA/Day Berlin 19 th September 2016 European Union Agency for Network and Information Security About ENISA 2 Positioning ENISA activities 3 ENISA and
More informationNavigating Regulatory Issues for Medical Device Software
Navigating Regulatory Issues for Medical Device Software Michelle Jump, MS, MSRS, CHA Principal Regulatory Affairs Specialist Stryker Corporation IEEE Symposium on Software Reliability Engineering (Ottawa,
More informationConformity Assessment Schemes and Interoperability Testing (1) Keith Mainwaring ITU Telecommunication Standardization Bureau (TSB) Consultant
Conformity Assessment Schemes and Interoperability Testing (1) Keith Mainwaring ITU Standardization Bureau (TSB) Consultant Moscow, 9-11 november 2011 Contents The benefits of conformity assessment Conformity
More informationGuidelines 1/2018 on certification and identifying certification criteria in accordance with Articles 42 and 43 of the Regulation 2016/679
Guidelines 1/2018 on certification and identifying certification criteria in accordance with Articles 42 and 43 of the Regulation 2016/679 Adopted on 23 January 2019 1 Table of contents 1.1 Scope of the
More informationList of EA Publications. Documents
EA/INF-01 List of EA Publications and International Documents Publication Reference EA-INF/01: 2014 List of EA Publications And International Documents PURPOSE This publication gives the list of EA documents
More informationApril 28, Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852
701 Pennsylvania Avenue, NW Suite 800 Washington, D.C. 20004 2654 Tel: 202 783 8700 Fax: 202 783 8750 www.advamed.org Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers
More informationECG200+ General Information. ECG200+ Product Code General Name
General Information Product Name General Name ECG200+ ECG200+ Product Code 80608066 Manufacturer Device Description Intended Use Cardioline Spa ECG200+ Registered Office and Factory: Via Linz, 19-20-21
More information