Seminar - Medical Device Regulatory Affairs and Quality Assurance
Nowadays, more and more countries in Asia, Europe and International markets are enforcing or in development of Medical device regulations. This Seminar is set to tackle the increasingly complicated International, Asian and European medical device regulations and quality requirements.
17 Sep 2015, 15:00
17 Sep 2015, 17:00
Hong Kong, China
[FULL] ALL SEATS RESERVED. THANK YOU FOR YOUR SUPPORT
Nowadays, more and more countries in Asia, Europe and International markets are enforcing or in development of Medical device regulations. This Seminar is set to tackle the increasingly complicated International, Asian and European medical device regulations and quality requirements. In this seminar, SGS, from both practical and academic perspectives, will share knowledge on medical devices regulations in major jurisdictions such as United States, Europe, ASEAN and Hong Kong, as well as how to maintain and apply them and avoid the pitfalls.
The seminar will introduce updated knowledge on the two subjects, with regulatory affairs aim to give both factual and practical knowledge of what is regulatory requirement and how to handle future regulatory tasks, such as the up-coming Qualified Person (QP) requirement for the European Union (Article 13); and quality and audit systems to provide for the risk-based requirements for quality manufacturing of the medical device products.
1) Medical device management
2) Medical device regulation overview and updates
3) Introduction to ISO 13485 as the basis of Medical Device Regulations worldwide.
4) Acquiring certification and become a MD RA/QA Professional or the EU Qualified Person (QP)
WHO SHOULD ATTEND?
1) Medical device manufacturer’s RA specialist
2) Management Representative,
- Quality Management / Engineering Management
- Management of Operations
1) Ir Albert Poon, Associate Specialist
- Chairman of Biomedical Discipline Assessment Panel of HKIE
- Medical Device Program of SGS
2) Mr. Kelvin Sze, Certification Officer of SGS HK
Date: 17 September 2015 | Time: 3:00pm – 5:00 pm
Venue: 5/F, Manhattan Centre, 8 Kwai Cheong Road, Kwai Chung
Fee: FREE OF CHARGE
Enquiry: Nancy Cheung (Email: firstname.lastname@example.org / Phone: 2204 8371)