Medical device contract testing laboratories are seeing more requests from MDMs for regulatory support (performing regulatory testing and maintaining appropriate quality systems – namely, ISO 17025).
In an effort to better serve the MDM community many test labs are pursuing ISO 17025 accreditation. This internationally recognized standard is considered essential for testing facilities around the world and accreditation provides formal recognition of technically competent testing organizations.
The accreditation process is voluntary and assessed periodically by an independent, third-party registrar. As such, a testing company’s laboratory and quality management systems are thoroughly evaluated for compliance with the ISO 17025:2005 standard. Accredited labs are then in a much better position to demonstrate that they are capable of producing precise and accurate test data, meaning the results can be relied upon. This can reduce costs for MDMs by reducing the need for redundant audits of its suppliers, who have been through the rigorous scrutiny of its daily laboratory practices and hold that accreditation. It can also eliminate potential trade barriers.
ISO 17025 accreditation ensures continued technical competence and puts testing labs in a favorable position to provide more development support for medical device companies with regard to testing, where there has been a recent uptick. Accurate and reliable testing during development phase work is seen as value-added as issues can be identified much farther upstream (when those issues can be corrected easily and cost-effectively).