on 21 November 2022 | By Andrew Tarnaris, M.D. MD (Res) FRCS (NeuroSurg), RQM+ Medical Director
A new opinion (CECP-2022-000222) provided under the Clinical Evaluation Consultation Procedure (CECP) was recently published by the European Commission. Here are some things worth noting, a summary to digest and lessons learnt both for manufacturers and notified...
Read Moreon 8 September 2022 | By Andrew Tarnaris, M.D. MD (Res) FRCS (NeuroSurg), RQM+ Medical Director
Pappalardo F et al. published a recent paper (in the IEEE JOURNAL OF BIOMEDICAL AND HEALTH INFORMATICS) advocating for a roadmap towards the CE marking of medical devices based on in silico trials. In silico trials simply mean the use of computer modelling and simulation in...
Read Moreon 10 May 2022 | By Andrew Tarnaris, M.D. MD (Res) FRCS (NeuroSurg), RQM+ Medical Director
State of the art (SOTA) is a key element of the technical documentation required for MDR/IVDR certification. As a new requirement for devices in lower-risk classes, many manufacturers are struggling to provide SOTA context that meets notified body expectations. Whether for new...
Read MoreGLOBAL BOTTOM CTA INSTRUCTIONS:
To display custom copy instead of global copy in this section, please go to Show Global Content for Bottom CTA? toggle in the "Contents" tab to the left, toggle it off, save, and then REFRESH the page editor, the custom text will then show up and ready to be edited.
Turning the global content back on will be the same process, go to the toggle and toggle it back on, save and refresh!
United States HQ 2790 Mosside Blvd. United States (U.S.) |
Europe HQ Blenheim Court Nottingham, NG1 3BY |
©2023 RQM+ All Rights Reserved | Privacy Policy | Terms of Use