MedTech news roundup September 2025
Our September 2025 MedTech news covers the latest regulatory updates from the EU, Switzerland, China, Canada, and Brazil. Find out…
Congenius
Categories
- All
- Clinical
- Congenius News
- eHealth
- Fact Sheets
- MedTech News
- Operations
- Quality
- Regulatory
- Social Responsibility News
- Spotlights
- Topical Articles
- What's New
MedTech news roundup Summer 2025
Our summer MedTech roundup gathers the latest in industry news from July and August from regulators around the world. Find…
Congenius
MedTech news roundup June 2025
Our June 2025 MedTech news covers the recent guidance from the MDCG on the interplay between the MDR/IVDR and the…
Congenius
ISO 10993-1 | What’s new in the latest draft standard?
ISO 10993-1 provides the governing foundation for the biological evaluation of medical devices, explaining the fundamental requirements and general principles.…
Congenius
MedTech news roundup May 2025
Our May 2025 MedTech news covers the Swiss Federal Council’s guidelines for expanding medical devices supply, an upcoming focus campaign…
Congenius
MedTech news roundup April 2025
Our April 2025 MedTech news covers new harmonised standards from the EU Commission, updates from MedTech Europe on IVDR, MDR,…
Congenius
MedTech news roundup March 2025
Our March MedTech news covers EU-US trade tensions, the Clean Industrial Deal, updated guidance on IVD classification, and calls for…
Congenius
Chemical Analysis for Biocompatibility Assessment of Medical Devices | Essentials from the FDA draft guidance
In September 2024, the FDA published its draft guidance on “Chemical Analysis for Biocompatibility Assessment of Medical Devices” to improve…
Congenius