Rare Disease Clinical Trials | Challenges & Solutions
In the European Union, a rare disease is defined as one that affects no more than 1 person in 2,000,…
Congenius
Categories
- All
- Clinical
- Congenius News
- eHealth
- Fact Sheets
- MedTech News
- Operations
- Quality
- Regulatory
- Social Responsibility News
- Spotlights
- Topical Articles
- What's New
How to streamline design transfer from manufacturer to supplier
Last year in our topical article How to optimize your supplier management, we examined the key issues, challenges, and opportunities…
Congenius
Artificial Intelligence in medical devices
Artificial Intelligence (AI) has the potential to revolutionise the healthcare industry by enhancing diagnostic accuracy, treatment efficiency, and patient care.…
Congenius
Developing medical devices for diverse patient populations: Challenges & considerations
The lack of diversity in healthcare is a topic that’s been written about for at least the last two decades.…
Congenius
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
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
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