Compliance & QMS for
Medical Devices & IVDs
Practical, audit-ready support from a certified Lead Auditor — ISO 13485 readiness and QMS implementation.
Credentials
Three focused practice areas
Everything a medical device or IVD manufacturer needs to stay audit-ready — delivered by one certified professional.
MDSAP & ISO 13485 Auditing
Independent, audit-ready assessments from a certified Lead Auditor.
Structured QMS audits aligned with ISO 13485:2016 and MDSAP requirements — an honest picture of where you stand before a Notified Body does.
- Gap assessments against ISO 13485:2016 and MDSAP criteria
- Supplier and sub-contractor audits
- Mock Notified Body audits to surface non-conformities early
- MDSAP readiness for FDA, Health Canada, ANVISA, PMDA, TGA
Medical & Technical Translation
Regulatory-grade accuracy for IFUs, labeling, and technical dossiers.
Medical translation carries regulatory weight. Precise, context-aware translation and proofreading of technical documents across markets.
- Instructions for Use (IFU) and labeling translation
- Linguistic validation of clinical documentation
- Terminology consistency across global submissions
- Technical dossier review for regulatory tone and accuracy
QMS & SOP Development
Practical quality systems built around how your team actually works.
QMS structures and core SOPs that stay audit-compliant without becoming a burden to maintain — built on tools you already use.
- SOP authoring: CAPA, ISO 14971, Post-Market Surveillance
- Document control with e-signatures and full audit trails
- QMS on Office 365 or validated open-source platforms
- Design & Development integration to prevent redesigns
Expertise rooted in real operations
R&D and Operations Director with Lead Auditor certification — practical advice that holds up in the field, not just on paper.
Certified Lead Auditor
Formal auditor certification combined with years of operational QMS experience across R&D and manufacturing environments.
Flexible Engagement
From a single SOP review to ongoing audit support — engagements scale to what you actually need, without retainer commitments.
Global Regulatory Scope
Practical knowledge of EU, US, Canadian, Brazilian, Japanese, and Australian frameworks for medical devices and IVDs.
Ready to get audit-ready?
Let's discuss where your QMS stands and what it takes to get it where it needs to be.
Get in Touch