Fundamentals of ISO 13485:2016 Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes
About This Course
Students will understand the requirements of ISO 13485:2016 and the design specifications for the 2016 version of ISO 13485, as well as the difference between ISO 13485:2003 and ISO 13485:2016. This course will prepare you to comprehend the intent and meaning of all clauses of ISO 13485:2016 and to recognize the interrelationship and linkages between the clauses and requirements.
Key Learning Objectives
At the end of this medical device QMS course, you will be able to:
- Identify key documents to help you understand ISO 13485:2016
- Recognize the primary elements of ISO 13485:2016
- Identify terms and definitions relative to the application of ISO 13485:2016
- Recognize similarities and differences between ISO 13485:2016 and the Quality System Regulation
- Demonstrate practical application of ISO 13485:2016 requirements through inspection scenarios
Who Should Attend
This course is vital for any medical device professional, including regulatory and quality directors, managers, engineers and auditors, who is responsible for implementing or working within a quality management system in accordance with ISO 13485:2016. This is a global standard, so it is applicable to devices intended for the market in any jurisdiction around the world.
Course tutors selected from the following:
Robert Ruff - Rob has over 30 years’ experience in the medical device and public health sectors, including completing a long, distinguished career with the U.S. FDA. His extensive regulatory experience includes co-authoring the MDSAP Audit Model and the Quality System Inspection Technique (QSIT). He also developed the FDA’s computer-based training for QSIT, the Quality System Regulation and the Medical Device Reporting Regulation.
James Pink - James Pink has over 20 years of experience in the medical devices industry, including 10 years as a health care technology expert and lead auditor for a prominent European notified body. He began his career as a product designer in the oil tools industry before moving into medical physics and clinical engineering at the Royal Hallamshire Hospital in Sheffield, UK. His industry experience includes managing product development and quality assurance programs for active and nonactive implantable and combination products. Mr. Pink is a contributor to several medical device standards committees, including ISO 13485, ISO 14971 and various product-related standards.