Course description
Fundamentals of ISO 13485:2016 Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes
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.
Upcoming start dates
Suitability - 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.
Training Course Content
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
Why choose NSF International, Health Sciences
Trained over 1,300 delegates on our CQI and IRCA certified GMP PQS lead auditor training course
Provided expert health sciences training for over 30 years
More people have become ‘Qualified Persons’ in Europe through our training programme than any other training provider
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