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Accelerate the compliance process of your product portfolio in line with the new Medical Device Regulation (EU 2017/745)
23 months
Total duration of the mission
3 submissions
MDR conformity upgrades (DHF, CER, PMD, CDP, IFU, ...)
1 submission
new MDR CE marking - Class IIb device
Background
Following the enforcement of the new European medical device regulation (EU 2017/745 or 'MDR'), our client, a recognized player in the medical device industry with 100+ references marketed in France and internationally, had to ensure product compliance for its product portfolio, in order to be able to continue commercialize them.
Challenge
• High and punctual peak of activity • Shortage of regulatory and clinical experts capable of preparing submission applications. • Extended evaluation delays by Notified Bodies. • Risk of a sudden drop in revenue due to delays in obtaining MDR certificates.
Approach
Our client wanted to support the skill development of its internal teams, as well as get additional manpower to better absorb the peak activity. Keyrus Life Science sent one of its senior Clinical Project Manager consultants, trained to the MDR, to directly integrate within its teams, whose role was to: • Establish standardized compliance processes, • Provide clinical expertise in the construction of applications for the client's priority products, • Support the internal teams and the other more junior consultants
Key results
Benefits
In addition to securing the CE marking of its strategic products, the clinical and regulatory expertise provided by the Keyrus consultant helped lay a solid foundation to facilitate the compliance of the rest of the client's product portfolio, and adapted to the client's strategy.
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