Medical Device Market Access Regulatory Training

This instructor-led, three-day course covers design control principles relative to the U.S. 21 CFR Part 820, ISO 13485:2016, the EU MDR, and EU IVDR utilizing key foundations of the risk management process defined in ISO 14971:2019.

This NSF 510(k) premarket course is available as corporate in-house training and can be delivered in a format and time frame that works for you and your team.

This EU MDR and EU IVDR technical documentation course is available as corporate in-house training and can be delivered in a format and time frame that works for you and your team.

This virtual instructor-led two-day course covers design control principles and design and development regulatory requirements relative to U.S. 21 CFR Part 820, ISO 13485:2016 and the EU MDR. Practical examples will be incorporated. This course covers important requirements for medical device and IVD design controls. Learners will benefit from open dialogue and the sharing of current design and development principles, including the interrelationship of risk management and design and development throughout the lifecycle of a device. 

To address some confusion surrounding the guidance Deciding When to Submit a New 510(k) for a Change to an Existing Device, the FDA has worked diligently to enhance predictability, consistency and transparency while maintaining a “least burdensome approach”.

The U.S. Food and Drug Administration’s pre-submission or Q-Sub Program is a voluntary mechanism to get FDA feedback on specific questions necessary to guide product development and/or application preparation.

Today’s medical device auditor needs auditing skills, technical skills and up-to-date knowledge of the latest regulatory requirements. Meet these needs with NSF.

Marketing a medical device in a global environment offers many challenges, as regulatory requirements vary widely from one country to another.

NSF’s training courses give you tools to ensure your product complies with international standards and regulations. Our diverse training programs teach you how to implement and apply global guidelines through all stages of the product lifecycle.