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.