5 learnings from FDA’s new Biocompatibility guidance
In October last year, the FDA published draft guidance regarding the biocompatibility of certain devices that contact intact skin. Our…
Congenius
Categories
- All
- Clinical
- Congenius News
- eHealth
- Fact Sheets
- MedTech News
- Operations
- Quality
- Regulatory
- Social Responsibility News
- Spotlights
- Topical Articles
- What's New
From start-up to exit: Expert advice on Bio & MedTech Entrepreneurship from our CEO
The process of innovation in life sciences is capital intensive – associated with high risk and strict regulations. In this…
Congenius
MedTech news round up December 2020
Our December 2020 MedTech news round up covers the Brexit impact on clinical studies, EC clarification on remote audits, FDA`s update on…
Congenius
Consultant Spotlight – Ivo Dolezal
Next to take our Consultant Spotlight hot seat is Ivo Dolezal. With over 17 years` experience in MedTech, Ivo shares…
Congenius
A guide to 510(k) Premarket Notification
What is the difference between a Traditional, Abbreviated and Special 510(k)? In which scenario should you use each submission type?…
Congenius
Ethics, Expectations & Education: What lies ahead for AI in medical devices?
Artificial Intelligence is changing the world. In a MedTech context, it enables a small team to affect many lives. To…
Congenius
The impact of Artificial Intelligence on the medical device industry
The responsible implementation of Artificial Intelligence within MedTech will transform the efficiency of the industry. But which areas within medical…
Congenius
Creativity meets philanthropy – A film that will improve the lives of children in India
At Congenius, we are committed to facilitating healthier lives, be that through our consultancy work in medical devices, or via…
Congenius