MedAware Systems

This Opinion from the EC reinforces the importance of comprehensive data for MDR submissions. The cost, in terms of time and effort, to resubmit can be significant, making "getting it right" the first time a priority. To see how MedAware Systems solves this problem, please visit www.medawaresystems.com.

https://lnkd.in/eQJRWcx

Clinical Trials Data | Medaware Systems Maximizing value from clinical trials research for Pharmaceutical and Medical Device Companies, Physicians, Payers, and Patients

In the absence of the European database on medical devices (EUDAMED), a series of clinical investigation application/notification documents have been created to support clinical investigation procedures with respect to MDR. These documents include: Clinical investigation – application/notification form under the MDR; Addendum to the clinical investigation application/notification form for various devices and sites; and Clinical investigation supporting documents.

Also included is an Appendix of documents to attach, Checklist of general safety and performance requirements, Standards, common specifications and scientific advice. Learn more at:https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-8_en.pdf

ec.europa.eu

MedAware Systems’ Science of Health Informatics (SOHInfo) announces a major upgrade of its medical device surveillance service to include reporting on social media posts.

This new functionality supports both FDA and MDR post market vigilance requirements. Learn more at:

medawaresystems.com