Seminar on Medical Device Regulatory Affairs and Quality Assurance

INTRODUCTION:

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, our speakers 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 from both practical and academic perspectives.

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 upcoming 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.

MAIN CONTENT:

• Medical device management
• Medical device regulation overview and updates
• Introduction to ISO 13485 as the basis of Medical Device Regulations worldwide.
• Acquiring certification and become a MD RA/QA Professional or the EU Qualified Person (QP)

WHO SHOULD ATTEND?

• Medical device manufacturer’s RA specialist
• Management Representative (Quality Management / Engineering Management/Management of Operations)
• Logistics and distribution professionals

SPEAKERS:

• Ir Prof. Albert Poon, Associate Specialist
  - Chairman of Biomedical Discipline Assessment Panel of HKIE
  - Medical Device Program of SGS
• Mr. Kelvin Sze, Certification Officer of SGS HK

GENERAL INFORMATION:

 

ENQUIRY:

 Nancy Cheung (Email: nancy-sm.cheung@sgs.com / Phone: 2204 8371)