Off-The-Shelf software in medical devices | FDA guidance
The FDA has issued updated guidance on Off-The-Shelf software in medical devices. The document, which supersedes a previous version issued…
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 July 2023
Our July 2023 MedTech news roundup covers the latest from Swiss Medtech on utilising FDA authorised medical devices in Switzerland,…
Congenius
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
MedTech news roundup June 2023
Our June 2023 MedTech news roundup includes Swissmedic’s Annual Report findings, updates from the MHRA on regulatory reform in the…
Congenius
Guide for start-ups – Regulatory Affairs & Design Assurance essentials
Start-ups that want to bring a medical device to market are inevitably confronted with a plethora of questions regarding compliant…
Congenius
Cybersecurity for medical devices
Medical devices are often connected to networks and can be vulnerable to cyber-attacks, which can compromise patient safety and the…
Congenius
Consultant Spotlight – Daniel Flury
Daniel Flury joined us in August last year as a Senior Consultant in the Quality team. In his Consultant Spotlight,…
Congenius
MedTech news roundup May 2023
Our May 2023 MedTech news roundup includes Swiss Medtech’s position paper on medical device procurement for the Swiss population, Swissmedic’s…
Congenius