Seminar on ISO 13485: 2016 & MDSAP - Understand the Transition & Implementation Rules of the New Standard

INTRODUCTION

With the latest regulatory development in US and EU, the industry is going to face new challenges. Are you ready?

ISO 13485:2016
The new version of ISO 13485 is published on 1 March 2016. With highly emphasis on regulatory requirement and risk management in all processes within ISO 13485. The full implementation of 2016 version will be in Mar 2019.

MDSAP
The Medical Device Single Audit Program (MDSAP) allows the conduct of a single regulatory audit of a medical device manufacturer’s quality management system (QMS) to satisfy the requirements of multiple regulatory jurisdictions. The full implementation of MDSAP will be anticipated in 2017.

CURRENT DIFFICULTIES FROM THE INDUSTRY

• Lack of awareness to MDSAP and its requirements
• Lack of understanding for the new version of ISO 13485
• Lack of knowledge in Medical Device Risk Management
• Inadequate experience in internal auditing

OBJECTIVE OF THE SEMINAR 

This seminar is to give advice to medical device manufacturers and any other interested parties on the critical steps to implement the necessary changes, and to present the key factors that to be success in these challenges.

AGENDA

• Requirements of MDSAP
• Difference between traditional QMS audit and MDSAP
• Major update in the ISO 13485:2016
• Transition arrangements of ISO 13485

SPEAKER

MR. FREEMAN FENG
Mr. Feng is the National Product Manager of the Medical Device Segment and the Leader Auditor in SGS. He has over 14 years of experience in the Medical Device industry and previously was product manager in in vitro diagnostic (IVD) manufacturing line.

WHO SHOULD ATTEND

• Medical Device Manufacturers
• Medical Device Subcontractor (OEM)
• Medical Device QA/RA Specialist
• Involving Parties in the Life Cycle of Medical Device

GENERAL INFORMATION