PFAS in medical devices
Per- and polyfluoroalkyl substances (PFAS) are set to be increasingly regulated in the EU. In our 5-minute guide below, our…
Congenius
Categories
- All
- Clinical
- Congenius News
- eHealth
- Fact Sheets
- MedTech News
- Operations
- Quality
- Regulatory
- Social Responsibility News
- Spotlights
- Topical Articles
- What's New
Artificial intelligence, machine learning & medical devices | 5 ways to mitigate knowledge gaps
Medical devices containing artificial intelligence (AI) or machine learning (ML) still pose significant challenges for regulatory authorities and manufacturers alike,…
Congenius
Clinical evaluation under MDR | Determining adequate clinical evidence
The introduction of MDR has significantly increased the importance of clinical evaluation for medical devices. And whilst several guidelines exist…
Congenius
How the AI Act, NIS 2, & Data Act will impact the EU medical devices regulatory landscape
Between August this year and September next year the regulatory environment in the EU regarding data will become more complex,…
Congenius
Design Control for Software | An introduction
The number of regulations, standards, and guidance documents specific to software in or as a medical device (SiMD, SaMD) is…
Congenius
A Regulatory Guide to Post-Market Surveillance
Post-Market Surveillance (PMS) according to MDR 2017/745 and IVDR 2017/746 is a systematic process to continuously monitor the safety and…
Congenius
Biocompatibility & Cleanliness Testing for Medical Devices
In the realm of medical technology and innovation, the development and production of safe and effective medical devices is of…
Congenius
Sorting the hype: The reality of AI application in medical devices
With extensive conversation and conjecture around Artificial Intelligence, it’s easy to lose sight of the technology’s true relevance to the…
Congenius