
01-03
2025
How to Publish Clinical Investigation Reports without EUDAMED

01-03
2025
Provide Recommendations for PCCP Tailored to AI-Enabled Devices

01-03
2025
FDA | 3P510(k) Review Program and 3PEUA Review

01-03
2025
The 2nd GHWP (Guangzhou) Academy Training Notice

01-03
2025
EU | Q&A on Vigilance Terms and Concepts as Outlined in MDR&IVDR

01-03
2025
10th NBs survey on certifications and applications (MDR/IVDR)

01-03
2025
MD Adverse Event Terminology and General Regulatory Requirements

11-04
2024
Borderline Between Medical Devices and Medicinal Products

11-04
2024
Regulatory status of EtO intended for the sterilisation of MDs

11-04
2024
FDA | Total Product Life Cycle Approach to IVDs
