Sterilization is a critical part of the product realization process for many medical devices. Vention Medical understands this and can provide a complete sterilization management solution.
We understand that each product is unique and presents its own challenges to the sterilization process. We are able to leverage our process knowledge and long history of successful relationships with many contract sterilization providers to be able to work with you in identifying the optimal sterilization method for your device. We regularly perform sterilization validations and manage routine device sterilization.
With over 800 employees and three manufacturing sites in North America, Vention Medical is able to offer a wide range of advanced technological solutions and support services to clients. We provide service to our customers for managing the sterilization validation for their product and then subsequent management of future lots. This includes protocol writing, sterilization supplier, audits, lot release, and records retention.
- Method selection (including packaging design recommendations)
- Initial cycle development
- Verification and validation
- Ongoing production sterilizations
- Batch release
- Routine quarterly and yearly validations requirements