Staying on top of changing regulations and expectations is challenging for MedTech regulatory professionals around the world. The following list is some of the educational resources that are most used by RA teams to stay current. With the exception of RAPS, we focused primarily on resources provided by regulatory agencies directly. Rimsys does not endorse or validate information on these sites.

Professional Organizations

Regulatory professional organizations provide a combination of free and paid training courses and certifications.  

RAPS

The Regulatory Affairs Professionals Society (RAPS) is the first stop for most regulatory professionals looking for education and certification:

• Courses (open to non-members) - includes RAC exam prep, online courses, webinar replays, and training bundles  
• Learning portal (RAPS members only)
• Connect RAPS (RAPS members only forum)

TOPRA

TOPRA is a professional membership organization for individuals working in healthcare regulatory affairs. TOPRA was founded in the United Kingdom and is active in Europe.

• Regulatory Affairs courses and webinars
• Conferences and networking events

Regulatory Agencies

United States (FDA)

The FDA offers a variety of free educational resources, including live and on-demand webinars, along with written documentation:

• Training and Continuous Education home page
• Continuing education programs
• CDRH Learn
• Guidance Webinars

EU Medical Devices Sector

• Event list (including educational webinars)
• Publications (including step-by-step guides)
• EUDAMED information center

Canada

• e-Learning courses on how medical devices are regulated in Canada

Singapore

While these are not training modules, the following free “tools” are available from the Singapore Health Sciences Authority:

• Is it a medical device?
  Answer a series of questions to determine if your device is considered a medical device in Singapore.
• Risk classification tool
  Answer a series of questions to determine the risk classification of your medical device.
• Registration and licensing requirements
  Answer a series of questions to determine the correct registration route.
• Medical device grouping tool  
  Answer a series of questions to determine if you can group your medical devices together for registration.

Additional third-party resources

Some sites that we find particularly useful. Note that Rimsys has no business relationship with these sites.

• Medical Device Made Easy podcast
• Medical Device Academy

Paid Resources

Notified Bodies and other large consulting firms can provide detailed training options, but these organizations are in the business of providing expert consulting and education, so these options are not free. Those listed here provide individual, self-service, training courses that are charged per-session:

• TUV SUD
• BSI

If you have any additional resources that you think we should include here, please connect with us on LinkedIn or Twitter!