Article
Articles
Article
Practical Advice To Leverage PCCP for Your SaMD
Article
What We Can Learn From Bluetooth Medical Device Recalls
Article
MedTech Regulatory Expert’s Insights on FDA 2022 Report
Article
Former FDA Official Grades ‘22 MedTech Industry Predictions
Article
2023 MedTech Industry Predictions from Former FDA Official
Article
FDA Pre-Cert Pilot: The Little Engine That Couldn’t (Yet)
Article
metaMe's Journey From Start-up to FDA Clearance
Article
How metaME Democratizes IBS Care with Prescription DTx
Article
End of the Line for EUA: Are You FDA Ready?
Article
New FDA Guidance: What You Need to Know in 2 Observations.
Article
Good Machine Learning Practices for Medical Device Development
SaMD Insights
White Paper
Software as Medical Devices (SaMD): What It Is & Why It Matters
Webinar
Sizing up SaMD Projects for Success
White Paper
PCCP for Class II SaMD Beyond AI/ML
Webinar
Regulation of SaMD in the U.S.
Article
Essential SaMD Regulatory Documents: Curated List
White Paper
Developing Successful Software as a Medical Device (SaMD) at Speed
Article
Top 10 SaMD Communities, Organizations & Working Groups
Webinar
