News | qtec group - Partner Medizintechnik / Clinical Affairs

19. March 2025

In Vitro Diagnostics manufactured and used within EU Health Institutions – In-House Devices (IH-IVD)

In-house IVD: in-house laboratory tests for safe and reliable diagnostics. Find out more about requirements and regulatory specifications!

20. February 2025

In vitro diagnostics – the importance of in vitro diagnostics for patient management and the health of society

In vitro diagnostics (IVDs) enable early disease detection & precision treatment. Learn how PCR, AI & lab tests improve healthcare & patient outcomes!

30. January 2025

Scientific Advice from the Medical Device Expert Panels on SARS-CoV-2-IVDs

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

Opportunity and challenge: Regulatory requirements for AI-based medical devices

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 for Information Technology Security Evaluation

Common Criteria (CC): International IT security standards for medical devices, supported by BSI and BfArM, enhance cybersecurity and trust in processes.

25. January 2024

Clinical evaluation of eyeglasses

Both prescription and non-prescription eyeglasses are considered medical devices under the regulatory framework of the Regulation (EU) 2017/745.

17. January 2024

Clinical Evaluation for Medical Devices in China

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

20 years of medical technology approval

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

Regulatory Affairs Update 25/23

Areas: Europe, Worldwide / Updates, New regulations and guidances 25/23

22. May 2023

PMS – Reports and Requirements

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

Risk assessment of zoonoses (3/3)

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

Risk assessment of zoonoses (2/3)

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.