MDR adherence | MDCG guidance for Clinical Affairs
Keeping track of the ongoing guidance for MDR adherence can be a time-consuming task. So to simplify your information-gathering process,…
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 round up September 2021
Our September MedTech news covers the latest updates and guidance from Europe, the US & Canada, and Asia Pacific. Read…
Congenius
Risk Analysis v FMEA: How knowing the difference benefits your risk management
Authorities ask Legal Manufacturers to perform a Risk Analysis for their Medical Devices according to ISO 14971. However, the expectation…
Congenius
The changing landscape for FDA EUAs
An Emergency Use Authorisation (EUA) allows the FDA to protect the health of the US public against chemical, biological, radiological,…
Congenius
Cobalt in medical devices: Do the benefits outweigh the risks?
In 2017, cobalt was up-classified by the European Chemicals Agency (ECHA) with respect to its carcinogenic, reproductive toxicity and mutagenic…
Congenius
8 tips for producing effective MDR Technical Documentation
Producing effective Technical Documentation provides manufacturers with their own central information source regarding their medical device. Accurate Technical Documentation can…
Congenius
MedTech news round up August 2021
Our August MedTech news covers the latest updates, guidance and position papers from the US & Canada, Europe & Switzerland,…
Congenius
Congenius welcomes Corinne Larke as new Head of Regulatory
We are delighted to welcome our new Head of Regulatory to the Congenius team. Corinne Larke joins us following over…
Congenius