News

Latest News

News

Latest News

5. August 2022

Clinical Evaluation of Software as a Medical Device

Which clinical strategy do I use to evaluate my software as a medical device according to MDCG 2020-1? We know the regulatory requirements.
1. August 2022

Regulatory Affairs Update /22

Areas: Europe, Worldwide / Updates, New regulations and guidances 31/22
21. July 2022

Life Cycle management tool support in the field of medical technology

Life Cycle management tool support in medical technology. DOORS, RQM or ELM - correctly manage requirements, tests, documentation and traceability.
24. May 2022

Regulatory Affairs Update 20/22

Areas: Europe, Worldwide / Updates, New regulations and guidances 20/22
16. May 2022

Extractable unknown substances or substances with missing toxicological data

Medical devices are often highly complex products made of different materials. About the handling of different substances.
25. April 2022

Regulatory Affairs Update 15/22

Areas: Europe, Great Britan, Taiwan, Australia and USA / Updates, New regulations and guidances 15/22
25. April 2022

AET – What is it?

The AET is an essential component for the biological safety assessment of the chemical characterisation of leachable substances in medical devices. Read details about the AET here.
1. April 2022

qtec Spotlight – Focused expert knowledge on medical technology

Qtec Spotlight is our focus on current topics from the medical device life cycle. Every quarter, our experts shed light on a specific area.
25. March 2022

Risk management and biological safety: A powerful team

Relevant aspects of biocompatibility of the essential safety and performance requirements for medical devices from Annex I of the MDR.
16. March 2022

Regulatory Affairs Update 11/22

Areas: Europe, Great Britan, Taiwan, Australia and USA / Updates, New regulations and guidances 11/22
12. July 2021

Person Responsible – Implementation of Article 15 MDR

As a partner in medical technology, our experts will assume the function of an external responsible person for your company if required.
1. April 2021

Regulatory Affairs Updates 13/21

Areas: Europe , MDCG updates, COVID-19, IMDRF, USA, Updates, New regulations and guidances "Issue" 13/21
qtec academy - Zulassung von Medizintechnik

Letzte Chance: 20% Rabatt

Jetzt zum Newsletter anmelden und 20% Rabatt auf die erste Buchung in der qtec Academy erhalten.
Jetzt anmelden
close-link