MDCG guidance roundup
As we snap back into action for 2023, here’s a quick roundup of some literature from the MDCG that you…
Congenius
Categories
- All
- Clinical
- Congenius News
- eHealth
- Fact Sheets
- MedTech News
- Operations
- Quality
- Regulatory
- Social Responsibility News
- Spotlights
- Topical Articles
- What's New
MDR latest | EU Commission calls for urgent amendment
At the EPSCO Council meeting last Friday 9 December, the EU Commission presented a legislative initiative to urgently amend the…
Congenius
How to achieve effective software segregation
The idea of breaking down a complex problem into smaller, more manageable challenges is a well-established concept. In software design,…
Congenius
Keeping Risk, Clinical and PMS connected under EU MDR
It’s undeniable that adherence to EU MDR requirements remains a challenge for everyone involved. And with the complexity of the…
Congenius
Understanding the dimensional stability of injection moulded consumables
Adherence to quality requirements for plastic components in MedTech is becoming increasingly important as MDR and IVDR dictate more stringent…
Congenius
Addressing the latest Cybersecurity legislation for medical devices
Many existing medical devices operate on legacy systems, which makes them difficult to maintain and vulnerable to manipulation by hackers.…
Congenius
Congenius Whitepaper | Overcoming the challenges of regulating combination products
Combination products have existed in both the EU and the US markets for several decades, but regulations for combination products…
Congenius
EUDAMED roundup | What’s happened and what’s next
The creation of a European database for registering certified medical devices is regarded as a cornerstone of the EU MDR…
Congenius