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.