Medical Device Seminar Bringing your medical products to United States of America (USA)

Transcription

1 Medical Device Seminar Bringing your medical products to United States of America (USA) 4 th June 2015 TÜV SÜD

2 Introduction Healthcare improvements rely on an innovative and diverse medical device sector around the world. But as the market grows, so too does the regulatory environment and the pressure on timelines. To guarantee swift market access, manufacturers must respond quickly and effectively to regulatory changes as they happen. They need to ensure that their products meet expectations of quality, safety and performance prior to launch in order to achieve quick, cost-efficient market acceptance. This seminar is specially organized for medical technology companies seeking entry to United States. At an estimated US$125.4 billion in 2013, the US medical device market is the world's largest. Per capita expenditure, at US$392, is the second highest in the world, behind only Switzerland. In addition, the medical device imports increased by 4.6% to reach a record high of US$37,751 million in The running annual total reached US$38.9 billion in the 12 months to August 2014, representing y-o-y growth of 5.1%. With the facts speaking for itself, the USA is the most attractive market in the world, particularly for commercializing a medical device (Source: BMI's Medical Device Risk/Reward Ratings (RRRs)). However, there is a challenge common to all medical device manufacturers. Due to the nature of the products to be used in healthcare, the market is very much regulated to ensure that patients have access to high quality, safe and effective medical devices. As such, this seminar aims to address this challenge by providing the local medical technology companies with good knowledge and understanding of what it takes to sell a medical device in the US market. 02

3 Who Should Attend This seminar is designed for a multidisciplinary audience of: Medical Device Business Owners Medical Device Companies CEOs Managing Directors and Directors Regulatory Affairs Directors/ Managers / Specialists Quality Assurance Directors/ Managers / Specialists Product Managers / Engineers and Medical Device Consultants About the Speaker Vice President Quality & Regulatory Affairs TÜV SÜD America Inc. Mr. Gary Minks is currently the Vice President of Quality & Regulatory Affairs for TÜV SÜD America Inc., overseeing all certification programs for both management systems and product certifications. He first joined TÜV SÜD more than 22 years ago as a Quality Systems Lead Auditor, and has since held several management positions. In his current role, Mr. Minks is responsible for all North American accreditations / recognitions that TÜV SÜD holds from both government and private agencies. These accreditations provide TÜV SÜD the authority to offer certifications in diverse areas such as Quality and Environmental Systems, Electrical Safety, Food Safety and Medical Device Regulations. Prior to joining TÜV SÜD America, Mr. Minks held quality management positions at several aerospace and medical device manufacturers. He graduated from the University of Massachusetts Lowell with a B.S. in Industrial Management and holds an M.B.A. from the University of Southern New Hampshire. He is also an ASQ Certified Quality Engineer (CQE), and Certified Quality Auditor (CQA). 03

4 Programme Outline Medical Device Seminar - Bringing your medical products to United States of America (USA) on 4 th June 2015 Time Topic 8.30 am Registration 9.00 am Welcome Address 9.15 am In the Medical Device Business and Experience Sharing Speaker: Ms. Mahsita Sari, Senior QA/RA Manager, ResMed am Coffee Break and Networking am Registering Your Medical Product in the US Market Speaker: Mr. Gary Minks, Vice President, TÜV SÜD America am Medical Device Pre-Market Testing Requirements Speaker: Ms. Chua Su Chen, Product Manager, TÜV SÜD ASEAN pm Questions and Answers pm Lunch Break and Networking 1.30 pm Medical Device Single Audit Program (MDSAP) Speaker: Mr. Gary Minks, Vice President, TÜV SÜD America 3.30 pm Tea Break and Networking 3.50 pm Electromagnetic Compatibility (EMC) for Medical Equipment Speaker: Dr. Deng Junhong, Vice President, TÜV SÜD ASEAN 4.45 pm Questions and Answers 5:00 pm End of Programme All information is accurate at the time of printing. TÜV SÜD reserves the right to make changes to the programmes due to unforeseen circumstances. 04

5 Medical Device Workshop - Bringing your medical products to United States of America (USA) on 4 th June Registration Form Complete the application form below and to Ms. Doreen Yeo by 26 th May Tel: / Fax: / doreen.yeo@tuv-sud-psb.sg Application Form: Company Name Number of Participants Company Address Telephone (Office): HP: Fax: a. Early bird discount fee Workshop fee of S$150 per person (excluding 7% GST) if registration and payment are received latest by 18 th May b. Normal registration fee Workshop fee of S$180 per person (excluding 7% GST) if registration and/or payment is received on 26 th May c. Group discount fee and Association of Medical Device Industry Singapore (AMDI) member only Workshop fee of S$120 per person (excluding 7% GST) for at least 3-5 participants from the same organization or AMDI member to register by 18 th May Enquiries Mr. Caleb Ng at DID: or caleb.ng@tuv-sud-psb.sg Payment Fax or scanned copy of payment receipt together with registration form to guarantee your seat, or In Cheque / Cash must be made (Prior to commencement*), payable to TÜV SÜD PSB Pte Ltd is required upon registration and must be received prior to the event to guarantee your seats. Refunds and cancellations are allowed if written notice is received 14 days prior to the date of the event. No refunds are allowed thereafter. If the registered candidate is unable to attend the seminar, please inform us in writing of the replacement candidate. The final decision will be at the discretion of the management. Substitution is encouraged and permitted when notified. TÜV SÜD PSB Pte. Ltd. No. 1 Science Park Drive, Singapore Tel Fax enquiries@tuv-sud-psb.sg