Compliance with ISO 10993 and ISO 18562
If you are planning to conduct biocompatibility or extractable/leachable studies on your device or materials, then it is important that these studies are performed to the highest possible standards in a cost and time-efficient manner.
Chorley Consulting can provide cost estimates for the commissioning, managing and monitoring of any studies. The services we can offer include:
- Coordinating test sample delivery to laboratory
- Discussing study design with laboratory
- Review of study protocols for GLP and regulatory standard compliance
- Approval of protocols on behalf of client (if required)
- Liaising with laboratory and client regarding timings and progress of studies
- Responding to any technical questions from the laboratory
- Review of study report and results
- If required by the client, or advised by Chorley Consulting due to non-standard study design or concerns over the laboratory’s technical ability, on-site study monitoring can be provided
Laboratory Audit
Technical ability, GLP compliance and animal welfare
Guidance for Notified Bodies auditing suppliers to medical device manufacturers indicates that a critical supplier is a supplier delivering materials, components, or services that may influence the safety and performance of the device. Contract Research Organisations (CROs) who conduct biocompatibility or extractable/leachable testing may therefore be considered as a critical supplier and audited/approved as part of your quality management system.
We have extensive experience in auditing laboratories around the world for technical ability, GLP compliance and animal welfare. We can audit laboratories on your behalf and make recommendations as to their suitability as a critical supplier. Some of the areas we focus on include:
- Technical ability
- Scientific integrity
- SOPs
- QA process
- GLP Compliance
- Animal facilities/welfare
- Study reporting