Industry News
The latest medical device regulatory news, clinical trials, and market insights
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.…
A Practical Guide to EU Market Approval for Medical Software
RAPS Nordic session with Health Tech Pathways and Scarlet: a practical introduction to navigating the EU MDR for medical software.…
Evolving QMS Maturity: Regulatory Strategies from Emerging Companies to Global Enterprises
RAPS Seattle virtual event on how quality management systems evolve as a medical device company grows. 1 CE credit. Date:…
Standards in Action: FDA’s ASCA Program, From Test Lab to Premarket Review
RAPS New Jersey and Philadelphia chapters host FDA and Intertek on how ASCA test reports are used in premarket review.…
Mastering the 510(k): Practical Strategies for Success with eSTAR
RAPS Colorado Chapter virtual event on preparing a 510(k) submission in eSTAR, beyond simply completing the template. 1 CE credit.…