Validation & Varification
A faster & smarter way to the market
Over the past few years, it has become evident that medical device companies are looking for ways to expedite approval processes of new designs. The development of a new customized service, a highly effective process for Joint Validation & Verification activities is a service offered by Elcam in order to meet this need and remove the burden from the medical device provider.
"Employing Elcam’s Validation & Verification (V&V) testing services not only helped the project move along more expediently, but it allowed our internal resources to be utilized more efficiently. Elcam was professional and comprehensive with all the required testing. We will certainly take advantage of Elcam’s V & V services for future partnership opportunities".
R&D Manager, BBraun Melsungen
This team approach rests on a number of key principles:
The Process
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Mutual Specifications
Development of mutual specifications for a product -
Mutual V&V
Development of mutual V&V plan including required tests and aging cycles and procedures, development of SOPs, division of costs and work pertaining to the project -
Service Delivery
Execution of the agreed V&V program and delivery of the service -
Regulatory support
Regulatory support and delivery of necessary documentation for 510k submission
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An Integrated V&V significantly improves approval process and time to market of the end product, while saving both sides a significant amount of resources.
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