12. July 2024
In this article, we would like to present the answers provided by our expert Prof. Michael Imhoff to the many exciting questions posed by our customers.
News
25. April 2024
The World Health Organization (WHO) is a specialized agency of the United Nations for public health, based in Geneva. It was founded on 7 April 1948 and has 194 member states. According to the WHO constitution, its goal is to achieve the best possible level of health for all people. The focus is primarily on combating infectious diseases.
5. April 2024
Japan is the second largest market for medical devices in the world and offers manufacturers a lot of potential. However, product approval there is a particular challenge.
2. April 2024
In recent years, South Korea has increasingly become an important market for medical devices. The requirements vary in this regard.
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.