Transition to ISO 13485:2016
The fundamentals of the Medical Device Single Audit Program (MDSAP) for Medical Device Manufacturers
1 or 2 days course, September 5-6, Washington DC area
Training course designed and delivered by our expert dedicated to the Transition to the new ISO 13485:2016 Standard
With over one million certified companies over the world, the international Quality Management System standard ISO 13485 is among the most commonly used.
Since its first publication in 1993, several revisions have taken place aligning the standard with the evolution of the industry and the market needs. The latest edition of ISO 13485 standard for the Medical Device Industry, ISO 13485:2016, was officially published February 25th, 2016.
Medical Device manufactures have yet to understand the changes involved to undertake a smooth transition of their QMS and maintain compliance.
- Describe the new concepts and definitions introduced by ISO 13485:2016.
- Learn and comprehend the key changes and regulatory requirements introduced in the 2016 version of ISO 13485.
- Understand the importance of gap assessment and transition timelines.
- Cross referencing between the former versions of ISO 13485 ( ISO 13485:2003 and NF EN ISO 13485:2012) and ISO 13485:2016 for a smooth transition.
|9:00 am – 12:15 pm||Transition to ISO 13485:2016
|12:15 pm - 1:00 pm||Lunch|
|1:00 pm- 5:00 pm||Practice session
|About the trainer|