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.
News
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
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.
28. April 2023
Medical devices whose components include materials of biological origin require special risk management. In the first part of our series of articles on “Zoonoses”, we tell you how to meet the requirements of the MDR.
13. April 2023
Areas: Europe, Worldwide / Updates, New regulations and guidances 15/23
4. April 2023
In China, Post Market Surveillance (PMS) is an important component of the regulation for medical devices, ensuring the safety and effectiveness of these products.
31. January 2023
Areas: Europe, Worldwide / Updates, New regulations and guidances 05/23