Medical Device Market Access Regulatory Training
Understanding the legal and regulatory framework for developing, marketing and distributing medical devices can be challenging.
NSF’s courses provide comprehensive instruction on bringing your product to market. Covering everything from how the U.S. Food and Drug Administration (FDA) classifies medical devices to how to prepare technical files, our experts are here to help.
Instructor-Led Courses
Design Controls for Medical Devices and IVDs
This 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.
510(k) Premarket Notification Workshop – Bringing Medical Devices to the U.S. Market
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.
Technical Documentation Academy — EU MDR and EU IVDR
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.
Online Self-Paced Courses
Design Controls for Medical Devices and IVDs
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.
Deciding When to Submit a New 510(k) for a Change to an Existing 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”.
FDA Presubmission Program – Requesting FDA Feedback
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.
FDA Inspections of Medical Device Manufacturers
In preparation for an FDA inspection, it is important to familiarize yourself with the tools used by FDA investigators to conduct the inspection and to assess inspection outcomes to determine if further FDA action is necessary.
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Auditor Training Covering Global Regulatory Requirements
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Country-Specific Regulations Training
Marketing a medical device in a global environment offers many challenges, as regulatory requirements vary widely from one country to another.
ISO Standards, QMS and GMP Training
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.
Interested in Corporate In-House Training?
Don’t see what your team needs? We can deliver a broad range of market access regulatory medical device courses in a format that works for you and your team.
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