20. February 2025
In vitro diagnostics (IVDs) enable early disease detection & precision treatment. Learn how PCR, AI & lab tests improve healthcare & patient outcomes!
News
30. January 2025
The Medical Device Coordination Group (MDCG) requested scientific advice from the European Medicines Agency (EMA) to re-evaluate the classification of SARS-CoV-2 in the context of in vitro diagnostic medical devices (IVDs).
20. August 2024
AI has the potential to revolutionize healthcare and improve the lives of millions of people - but only if it is used safely and reliably.
19. August 2024
Common Criteria (CC): International IT security standards for medical devices, supported by BSI and BfArM, enhance cybersecurity and trust in processes.
25. January 2024
Both prescription and non-prescription eyeglasses are considered medical devices under the regulatory framework of the Regulation (EU) 2017/745.
17. January 2024
The field of medical devices is rapidly evolving, and as technological advancements continue, so do the regulatory frameworks governing their approval and marketing.
22. November 2023
We are celebrating our anniversary. We have been a partner to the healthcare industry for 20 years and support companies with the approval of medical products
20. June 2023
Areas: Europe, Worldwide / Updates, New regulations and guidances 25/23
22. May 2023
The time has finally come: almost 1.5 years after the MDR came into force, the MDCG has published the long-awaited
guidance document for the preparation of the PSUR.
16. May 2023
In the last part of our series of articles on the topic of “Risk assessment of zoonoses”, we take a look at the planning, scope and process of literature research in accordance with ISO 22442-3.
11. May 2023
Which regulations and guidelines apply to materials of animal origin and the risk assessment of zoonoses? We will tell you in part 2 of our series of articles.
4. May 2023
Many problems lurk when collecting clinical data as part of the PMCF. We help you to create a sensible strategy.