Navigating Global Medical Device Inspections: Expectations from US, EU, China, Korea, and Japan
RAPS workshop comparing FDA, EU, MDSAP, NMPA and MFDS inspection expectations. 4 CE credits. Date: 2026-10-27 Location: Online (Virtual) Event
Health Canada’s Medical Device Single Audit Program (MDSAP) Updates 2026
RAPS Western Canada virtual event on the latest developments in the Medical Device Single Audit Program. 1 CE credit. Date:
Understanding Performance Studies Under IVDR
RAPS workshop for clinical affairs, regulatory and quality professionals on performance studies under the EU IVDR. 2 CE credits. Date:
Clinical Evaluation for Medical Devices
RAPS workshop: a 16 hour course across four half days on the EU clinical evaluation requirements for medical devices. 12
Cybersecurity Unauthorized: The Latest in Medical Device Cybersecurity
RAPS workshop on the changing global cybersecurity requirements for medical devices. 12 CE credits. Date: 2026-10-13 to 2026-10-15 Location: Online
Proposals MDR 2.0, IVDR 2.0 and the Digital Omnibus
RAPS Netherlands Chapter meeting on the European proposals for MDR 2.0, IVDR 2.0 and the Digital Omnibus. Held in Dutch.
How to Validate AI Under FDA’s Computer Software Assurance Guidance
Webcast applying the risk-based principles of the FDA’s Computer Software Assurance guidance to artificial intelligence. 1 CE credit. Date: 2026-09-24
Validate your EU MDR/IVDR Knowledge for the PRRC Role
RAPS webcast on the Regulatory Compliance Credential and what it covers for the Person Responsible for Regulatory Compliance role. 3
Mastering Notified Body Opinions for Drug-Device Combination Products under EU MDR 2017/745
RAPS workshop on the submission process for Master Notified Body Opinions covering drug-device combination products. 4 CE credits. Date: 2026-09-03
Biocompatibility Essentials for Medical Devices: From ISO 10993 to US and EU Regulatory Expectations
RAPS Twin Cities session on biological evaluation of medical devices under ISO 10993 and what US and EU reviewers expect.