Medical devices (MD) are specific products that are used at different stages of medical therapy from the diagnosis, throughout the treatment and monitoring. Whether your medical device is an active implant, an IVD or a classic medical device, compliance with the essential principles of safety / performance / effectiveness must be demonstrated.
In this business cases, we were called by a startup who had been confronted by the National Competent Authority for having palced on the market an active electromedical product that was qualifying as a medical device without the proper CE mark. Time was of the essence.
The essential pieces of evidence that are usually assembled during the design, development, and industrialization were missing to form a comprehensive Technical Documentation. Therefore, we helped the Client rebuilding the missing protocols and reports within a very tight timeline by delegating a regulatory and quality engineer on-site to coach the team and review the documentation. We also established a compact and simple QMS in order to gather the essential ISO 13485:2016 certification.
In parallel, we initiated a relationship with a Notified Body and helped the company to find an availability slot. We also took care of the preparation of a Summary Technical Documentation (STED) that would ease the review process for the Notified Body.
After 5 months, the company could obtain a class IIa MDD CE mark.
Medidee may drive the project for you and/or assist your team in the following areas: