We offer comprehensive auditing services to ensure your medical devices and in vitro diagnostics (IVDs) comply with international standards and regulations. Our auditing solutions are designed to enhance your Quality Management System (QMS) and facilitate market access.
Internal Audits
Internal audits are vital for maintaining and improving your QMS. We conduct thorough assessments to ensure compliance with:
- Medical Device Regulation (EU) 2017/745 (MDR)
- In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR)
- EN ISO 13485 latest version
- 21 CFR Part 820 (FDA QSR)
- Medical Devices Regulations (SOR/98-282)
Our internal audits help identify areas for improvement, ensuring your QMS remains effective and compliant.
Supplier & Subcontractor Audits
Managing your supply chain is crucial for product quality and compliance. We perform audits on your suppliers and critical subcontractors to verify adherence to:
- MDR (EU) 2017/745
- IVDR (EU) 2017/746
- EN ISO 13485 latest version
- 21 CFR Part 820
- Medical Devices Regulations (SOR/98-282)
These audits ensure your partners meet the necessary quality and regulatory requirements, reducing risks in your supply chain.
Contract Auditing for Notified & Accreditation Bodies
With extensive experience, including over 30 audits as a former Lead Auditor for a Notified Body, we offer contract auditing services:
- Conducting audits in accordance with MDR and EN ISO 13485 standards.
- Performing technical dossier reviews for MDR compliance.
- Executing audits for accreditation bodies to assess conformity with EN ISO 13485.
An up-to-date NBOG (Notified Body Operations Group) reference can be provided upon request
Ensure your organization meets all regulatory requirements with our expert auditing services. Reach out to our senior consultant, Lizette de Groot, for personalized support.