CiteMed was founded to help facilitate the widespread regulatory bottleneck poised to impact medical device manufacturers in 2020 with the issuance of the Medical Device Report (MDR) requirements.
The new regulation has no accommodations for lead-in time. All Medical products and devices must have adhered to these guidelines and be approved through country identified notified bodies in order to be sold and marketed in over 39 countries within the EU.
Resources and expertise in preparing the essential Literature Reviews and Clinical Evaluation Reports (CERs) are becoming limited with the upcoming frenzy caused by this new regulation. Our solution is both a time-efficient and cost-effective solution for any size company required to maintain a Design History File and Risk Analysis Program.
Let us help you stay competitive in the European medical device marketplace as a responsible, risk-aware and compliant manufacturer or distributor.