We assess the conformity and performance of your quality management system against ISO 13485 and applicable regulatory requirements.
Independent and structured analysis
A global view of processes and their effectiveness
Targeted actions to strengthen conformity and control
Where are you in your ISO 13485 journey? Each situation calls for a different type of intervention.
The notified body has set a date. The audit programme has been received. The team knows there are gaps: incomplete records, procedures that have not been updated since the last product change. An internal audit conducted now identifies what an external auditor will find in six weeks.
The last audit report listed gaps in records control or non-conformity management. Corrective actions were closed. The same findings recur at the next audit. This is not a rigour problem — it is a QMS problem. A gap addressed superficially reappears because the root cause was never addressed at system level.
First certification, or a rebuild after years of operating without a formalised system. The standard has been read; the requirements are known. What is missing: an external perspective from someone who has seen the same mistakes at other manufacturers, before the notified body does.
Your QMS exists, but no one has looked at the whole system for a long time. Procedures have evolved with products, records have accumulated, responsibilities have changed. Before committing to a certification or a rebuild, an honest assessment is needed.
A report structured by severity level, distinguishing major non-conformities, minor non-conformities, and observations. Each finding is referenced to the relevant ISO 13485 clause. A prioritised action plan with recommended timelines is attached to the report.
ISO 13485 requires an annual internal audit covering the entire system. In practice, critical clauses (non-conformity control, complaint management, process validation) deserve more regular attention. Outsourcing this audit brings a perspective the internal team cannot have on its own system.
A full audit conducted in accordance with ISO 19011, a report with findings classified by severity, a review of open corrective actions. Deliverables transmitted within 10 business days after the intervention.
The notified body has set a date. A mock audit conducted under the same conditions as the real audit identifies the remaining non-conformities before the official assessment. This is not a rehearsal — it is the only way to know what an external auditor will find before they find it.
An audit simulation conducted by an AFNOR-qualified auditor, under certification audit conditions. Full findings report, prioritised corrective action plan, follow-up checkpoint before the audit date.
The critical gaps in a medical device SME's QMS are not in clause numbers. They are in the interfaces nobody documents: between design and production, between risk management and validation, between written procedures and what actually happens at the workstation.
An auditor who has only ever audited systems does not see these areas. We see them because we built and maintained QMSs before auditing them. The difference is not methodological. It is a matter of perspective.
Our priority: verifying that conformity evidence exists where a notified body will look for it, and that the system's critical interfaces are documented — not just the clauses.
Conducted at class I to IIb manufacturers across France and Europe. Internal audits, pre-certification diagnostics and mock audits in accordance with ISO 19011.
We understand the constraints of an SME maintaining a QMS with a small team.
Manufacturers, subcontractors, importers. Classes I, IIa and IIb. Sectors: imaging, orthopaedics, in vitro diagnostics, connected devices.
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Other services
MDR regulatory consulting for manufacturers
Technical file, CE marking, risk management ISO 14971. For manufacturers building or maintaining their MDR 2017/745 conformity.
Quality and regulatory consulting
ISO 13485 QMS, regulatory strategy, quality and market access alignment. For manufacturers who need an overall framework.
A 30-minute initial call is sufficient to assess your situation and define the scope of intervention. Quote provided within 48 hours; intervention possible within 3 weeks.