As former Lead Auditor of a Notified Body, with experience over 30 audits, Groots In Vitro Diagnostic Expert can support you with auditing.
Internal audits
Groots In Vitro Diagnostic Expert can execute your internal audits. Internal audits are an important tool to improve your Quality Management System.
Compliance of the following audit requirements can be covered during the internal audit(s):
- Medical Device Regulation (EU) 2017/745
- In Vitro Diagnostic Medical Device Regulation (EU) 2017/746
- EN-ISO 13485 latest version
- ISO 9001 latest version
- 21 CFR 820
- Medical Devices Regulations (SOR/98-282)
Supplier/ subcontractor audits
Groots In Vitro Diagnostic Expert can execute your supplier or (critical) subcontractor audits. Supplier and subcontractor audits are an important part of the supplier control process.
Compliance of the following audit requirements can be covered during the supplier and subcontractor audits audit(s):
- Medical Device Regulation (EU) 2017/745
- In Vitro Diagnostic Medical Device Regulation (EU) 2017/746
- EN-ISO 13485 latest version
- ISO 9001 latest version
- 21 CFR 820
- Medical Devices Regulations (SOR/98-282)
Contract Auditor for CE and EN-ISO 13485
Groots In Vitro Diagnostic Expert can act as excellence contractor:
- for Notified Bodies to execute audits conform the MDR & EN-ISO 13485 and to execute MDR technical dossier reviews;
- for accreditation bodies to execute audits conform the EN-ISO 13485 latest version quality management systems standard
An up-to-date NBOG can be provided upon request.
Do you need an auditor?
Contact our senior consultant Lizette