EU MDR / IVDR & MDSAP Audits
Internal audits (EU MDR / IVDR):
Internal audits are a strategic examination of your QMS against ISO 13485, MDR or IVDR. Our team — composed of ex-notified body and lead auditors — ensures a thorough evaluation and delivers actionable insights to drive ongoing QMS improvement.
Trusted by top-tier teams worldwide
Supplier QMS audits:
We audit your subcontractors and partners (e.g. distributors, suppliers, manufacturers) against relevant standards. This strengthens supply chain control, ensures compliance, and supports better partner decision-making.
MDSAP internal audits:
Recognised across the US, Canada, Brazil, Australia, and Japan, MDSAP audits ensure multi-market access through a single audit. We assess your current state, prepare your organisation for certification, and guide remediation.
Remote or desktop audits:
Flexible auditing options covering ISO 13485, FDA QMSR, and other standards. Benefit from time-efficient expert audits conducted virtually, while maintaining full regulatory compliance and QMS performance.
Featured case studies
Prosthesis manufacturer
Prosthesis manufacturer Introduction As part of their international development strategy, our client wanted to get MDSAP certified with a focus on Canada, Australia and Brazil. They were MDSAP certified within 7 months. Types MDSAP Audit Preparation, Quality Management System Review Scope of work Selecting the certification body (quotes, Q&A) Review of their quality management system…
Quarterly Internal Audits
Quarterly Internal Audits Introduction Quarterly Internal Audits Our client is a start-up medical device manufacturer of a body cooling device, for those with heat stroke. They are based in the UK and are undergoing ISO 13485 certification. Standards & Tools 21 CFR ISO 13485 MDSAP MDR Scope of work Key numbers Excited to work together…