For Medical Device Clinical Evaluation, we have the talents with cross-platform expertise and in-depth knowledge in MDR Article 61 & Meddev 2.7/1 Rev.4, to start a project right away!
Trying to do it in-house could involve employee hiring, training, and providing the support they need, all of which will cost your time, money and finally no assurance of success.
MEDDEV 2.7/1 Rev.4 is the guideline that will guide you to conduct Clinical Evaluation of your device!
The MDR regulation has brought about significant changes in the CER compared to the previous Directive
Meddev 2.7/1 Rev. 4 CER gap analysis will help you identify where you need further support in the CER!
Post Market Surveillance (PMS) will help you keep a check on your device after it has been placed on the market!
PMCF confirms the clinical performance & safety of device, ensuring the acceptability of the residual risks.
Brainstorming Interactive Ideas on MDR Article 61!
Here are a few challenges that we have heard from the medical device manufacturers
New MDR Classification
Clinical testing requirement for products earlier exempted, Interpretation of scientific Clinical data, availability & readiness of CER throughout the year
PMCF & PSUR Compliance Monitoring
Keeping track of annual safety updates and maintaining dynamic data records
Establishing "State of the Art"
Establishing state of the art (SOTA) with an extensive amount of supporting clinical data, the outcome of benefit-risk analysis and results of applicable bench testing
We are a Bunch of Regulatory Professionals & Clinical Writers
We solve every obstacle in the path of MDR Article 61 and Meddev 2.7/1 Rev. 4 compliance.
Documents for Sale!
World's first company to release a complete set of editable procedures and templates for sale!!