Clinical Evaluation under MDR: 5 tips for producing compliant CERs
Following a four-year transition period, MDR finally became fully applicable on 26 May 2021. Since this date, clinical evaluations for…
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 round up December 2021
This month’s round up covers the latest on Swiss Medtech’s import concerns in relation to Switzerland’s third country status, updated…
Congenius
Key learnings from ISO 10993-23:2021: Biological evaluation of medical devices – Tests for irritation
ISO 10993-23:2021 Biological evaluation of medical devices – Part 23: Tests for irritation assesses the possible contact hazards from medical…
Congenius
MedTech news round up November 2021
This month’s round up covers a first-of-its-kind publication from the WHO, a collaboration between the FDA, Health Canada and the…
Congenius
Preparing your Premarket Submission for Device Software Functions
The FDA has recently published draft guidance regarding the content of premarket submissions for device software functions. The guidance provides…
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
2021 charity donation beneficiary: The Theodora Foundation
As the saying goes, “Laughter is the best medicine”. With this firmly in mind, the Theodora Foundation charity works to…
Congenius
MedTech news round up October 2021
This month’s roundup covers MedTech updates from the EU & Switzerland, the latest guidance and resources published by the FDA,…
Congenius