Course description
Medical Device Regulatory Requirements - (5 course bundle)
Bundle of 5 Courses - Medical Devices Regulatory Requirements.
United States, Japan, Australia, Brazil, Canada
A comprehensive overview of each countries' Medical Device regulatory framework, including both Premarket AND Postmarket requirements. Learn what it takes to bring a product to market in each country and KEEP it there! You’ll also be introduced to the Medical Device Single Audit Program (MDSAP), and learn how each country is utilizing MDSAP. Includes competency assessments to provide documented evidence for the training requirements of ISO 13485:2016, the International Quality Management System Standard.
Upcoming start dates
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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Expenses
Multiple participant and early bird booking discounts available. Discounts also offered to NHS staff, regulators and charities.