MedTech news round up January 2021
January 2021 has been a busy month for the industry, with updates to standards, new guidance releases and measures taken…
Congenius
Categories
- All
- Clinical
- Congenius News
- eHealth
- Fact Sheets
- MedTech News
- Operations
- Quality
- Regulatory
- Social Responsibility News
- Spotlights
- Topical Articles
- What's New
A guide to the PMA application process
Premarket approval (PMA) is the most stringent type of device marketing application required by the FDA. Find out when a…
Congenius
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In October last year, the FDA published draft guidance regarding the biocompatibility of certain devices that contact intact skin.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
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