If you need help with auditing, whether that be audit training, internal, supplier or mock external audits, who would you want to do them?
You would want a team of medical device professionals that has extensive experience in conducting audits of all types, maybe you would also want a team that conducts audits on behalf of a Notified Body. We are that team.
Not only can we conduct an audit with the scrutiny you would expect from a high-quality audit, as consultants we can also help you remediate the findings.
We are here to ensure your medical devices are compliant every step of the way.
We can support you with:
▪ Audit training
▪ Internal audits
▪ Supplier audits
▪ Mock external audits (ISO 9001/ISO 13485/MDSAP)
▪ Stage 1 & 2 audits
▪ Audit remediation
▪ Verification and Validation
▪ Supplier management
▪ Product registration
▪ Recalls and Adverse Event management
▪ Product Design