Joint Validation and Verification - Verdict Medical Devices
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Joint Validation and Verification

Joint Validation and Verification

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 customised service, a highly effective process for joint validation and verification (V&V) activities, is a service offered by Elcam to meet this need and remove the burden from the medical device provider.

When an original equipment manufacturer (OEM) sources certain critical components from a supplier, the component must comply with specifications and be validated for a certain application and guarantee that a product can be manufactured reliably and repeatedly.

Many companies invest efforts and valuable time in product or component acceptance activities. The traditional V&V approach in sourcing a new or substitute component is usually done in series of stages on both sides – component manufacturer and OEM.

A mutual V&V integration programme can help alleviate the device provider’s workload. This programme can significantly accelerate the end product’s approval process and time to market, as well as saving the provider a significant amount of resources.

Joint V&V programme

The joint V&V is a service programme offered to streamline the V&V process of integrating a new component into a medical device or set. This service aims to build one mutual V&V plan instead of two separate ones to utilise resources most efficiently.

Elcam offers a joint V&V program that includes the following elements:

  • Development of mutual specifications for a product
  • Development of a mutual V&V plan, including required tests and ageing cycles and procedures, development of SOPs, division of costs and work pertaining to the project
  • Execution of the agreed V&V program and delivery of the service
  • Regulatory support and delivery of necessary documentation for 510k submission

Download the attached white paper for further data and information about the V&V service.

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