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
How to maintain an effective QMS
Maintaining an efficient and effective Quality Management System (QMS) over time is a substantial challenge. But what makes it so…
Congenius
How will the EU Packaging & Packaging Waste Regulation (PPWR) impact the medical device industry?
The European Union’s Packaging and Packaging Waste Regulation (PPWR) represents a cornerstone in the EU’s broader environmental and circular economy…
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
Post-market clinical follow-up under the EU MDR
Post-market clinical follow-up (PMCF) has become significantly more rigorous under the EU MDR to ensure enhanced patient safety following a…
Congenius
How to integrate an ISMS into your existing QMS
In the MedTech industry, information security is not just an IT issue – it’s fundamental to patient safety. MedTech companies…
Congenius
Subscribe to our monthly knowledge update