Validations

The selection of the correct materials and packaging format is essential in ensuring protection and maintaining sterility for the packaged life of the sterile medical device.

Validation of the chosen package is an integral part of its technical file and an essential requirement for CE accreditation.

Packaging Validation service in full.

Each validation is bespoke to customer product requirements and would involve a selection of appropriate tests.

Sterilisation Validations for ETO or Gamma Irradiation can also be arranged and monitored in accordance with ISO 11135 and ISO 11137.

CE accreditation for Class I sterile devices and a number of Class IIa medical devices.