Risk Analysis vs FMEA – What’s the difference?
According to ISO 14971, legal manufacturers are required to perform a Risk Analysis for their medical devices. However, the expectation is that…
Congenius
Categories
- All
- Clinical
- Congenius News
- eHealth
- Fact Sheets
- MedTech News
- Operations
- Quality
- Regulatory
- Social Responsibility News
- Spotlights
- Topical Articles
- What's New
Risk management for software
In our free whitepaper below, our Head of Quality Dr Dirk Hüber addresses the certain challenges and special aspects that…
Congenius
How to connect failure modes and risks in a risk management file
In September we shared an article from our Head of Quality Dr Dirk Hüber on the purpose and methodology differences…
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