Fill in and submit the form to
download our service package
Elcam Launches
a New Service:
Joint Validation and
Verification (V&V) testing
Over the past few years, it has become evident that medical device companies are looking for ways to expedite approval process of new designs.
The development of a new customized service, a highly effective process for Joint Validation & Verification activities is a new service Elcam is offering in order to meet this need and remove the burden from the medical device provider.
This team approach rests on a number of key principles

1

Up-front assessment
of risks.

2

A clear definition of the scope
and extent of the validation,
development and approval of SOPs

3

Specifications and agreed
upon test execution
Faster and smarter way to the market: Download an introductory whitepaper
Contract
review
Development of mutual specifications for a product
Mutual
specifications
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
Mutual
V&V plan
Execution of the agreed V&V program and delivery of the service
Service
delivery
Regulatory support and delivery of necessary documentation for 510k submission
Regulatory
support
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.