ISO 13485:2016 Requirements
2-day training session
2-day training session
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 on February 25th, 2016. Medical Device manufactures have yet to understand the changes involved to undertake a smooth transition of their QMS and maintain compliance.
GMED North America’s “ISO 13485:2016 Requirements” training course will provide the attendee with a general understanding of the concepts of the ISO 13485:2016 standard and how the requirements impact the day-to-day operations of organizations in the Medical Device industry. You will learn about the clauses of ISO 13485:2016 in detail, and also participate in group exercises and in-depth discussions.
Attendees successfully completing this course receive a Certification of Completion from GMED NA.
Sign up today and join our intensive 2-day course on the ISO 13485:2016 Requirements.
Acquire a solid foundation so that you and your team are prepared to tackle through practical cases, working sessions, discussions with our expert trainer, and the challenges of the standard.
REQUIRED LEVEL
A prior review of the ISO 13485:2016 standard is recommended for this course.
Who Should Attend:
NOTE FOR ONLINE TRAINING
Attendees need to connect to the class from any internet accessible location.
Webcam and Microphone are REQUIRED.
We offer a variety of training courses and we focus on your challenges and provide our attendees with a clear “take-home” value.