17. January 2024Clinical Evaluation for Medical Devices in ChinaThe field of medical devices is rapidly evolving, and as technological advancements continue, so do the regulatory frameworks governing their approval and marketing.
5. August 2022Clinical Evaluation of Software as a Medical DeviceWhich clinical strategy do I use to evaluate my software as a medical device according to MDCG 2020-1? We know the regulatory requirements.
21. July 2022Life Cycle management tool support in the field of medical technologyLife Cycle management tool support in medical technology. DOORS, RQM or ELM - correctly manage requirements, tests, documentation and traceability.
28. October 2021Impact of the MDR on Quality Assurance Agreements (QAA)We will show you why a quality assurance agreement is an important and central document of the MDR, and should make sure it is always up to date.