Internal and second-party auditing under ISO 13485:2016, the MDSAP Audit Approach and ISO 19011:2026. Conducted by accredited lead auditors, with reporting in the format expected by Auditing Organisations.
Internal auditing is a central element of MDSAP, explicitly required in process P3 (Measurement, Analysis and Improvement). More than a formal requirement, it demonstrates the QMS's capacity for continuous self-assessment - and distinguishes companies that pass from those receiving findings during certification.
Three types of audit, selected according to the objective: certification preparation, certificate maintenance or critical supplier assessment.
A complete QMS assessment across all 7 processes (P1-P7) of the MDSAP Audit Approach. For companies preparing for certification or fulfilling the mandatory annual cycle.
A replication of the technical rigour of an official MDSAP audit, with interviews, verification of objective evidence and simulated reporting structured by nonconformity level.
Auditing critical suppliers, third parties and strategic partners. For initial qualification or ongoing performance assessment under P7 requirements.
An audit planned and conducted under ISO 19011:2026, with formally defined criteria, scope and sampling throughout.
Formal definition of scope, criteria, objectives and sampling. Preliminary document review and alignment with senior management.
Opening meeting, interviews, document verification and sampling of objective evidence under the MDSAP Audit Approach. Full coverage of P1 to P7.
Categorisation of findings using the Grading System (Grade 1 to 5). Distinguishing documentary deviations from systemic failures affecting device safety.
A formal report with sampled evidence, categorised findings, proposed root causes and a CAPA action plan with deadlines, assigned owners and effectiveness indicators.
MDSAP categorises nonconformities into 5 levels. We distinguish documentary deviations from systemic failures.
| Grade | Severity | Characteristic |
|---|---|---|
| G1 | Minimal | A minor deviation with no direct impact on device safety or performance. Straightforward remediation, often documentary. |
| G2 | Moderate | A documentary nonconformity that may develop into a systemic failure if left unaddressed. Requires formal root cause analysis. |
| G3 | Significant | A failure affecting the robustness of the QMS or a critical process. A mandatory action plan with an effectiveness indicator. |
| G4 | Critical | A systemic failure with a potential impact on device safety or performance. Requires immediate action. |
| G5 | Major | A direct risk to patient safety or the device's regulatory compliance. Immediate communication to the authorities. |
A complete document in the format expected by AOs: scope, criteria, sampled evidence, categorised findings (Grade 1-5) and proposed root cause analysis.
Structured CAPA with corrective and preventive actions, formal deadlines, named owners and objective post-implementation effectiveness indicators.
Ranking gaps by criticality, considering residual patient risk, regulatory impact and remediation complexity. Directing effort towards what matters.
A closing meeting with senior management, presentation of findings, agreement on deadlines and owners, and definition of the implementation follow-up plan.
Our MDSAP internal auditing follows the official Audit Approach and ISO 19011:2026, with outputs in the format expected by the Auditing Organisations of the five regulatory authorities.
Questions we receive before starting an MDSAP internal audit.
Yes. Process P3 (Measurement, Analysis and Improvement) requires a formal internal audit programme under ISO 13485 and ISO 19011. Without records of completed audits and addressed findings, the QMS is not ready to obtain or maintain MDSAP certification.
Yes. A complete internal audit fully covers all 7 processes (P1 to P7), with official tasks and linked items. For mature QMSs, we audit by critical process or cycle (six-monthly/annually), according to the company's governance strategy.
Yes. The report follows the format expected by Auditing Organisations: scope, criteria, team, sampling, evidence, Grading System findings (Grade 1 to 5) and a CAPA plan. This is precisely the type of output the certification body seeks during the certification audit.
It depends on company size, portfolio complexity and QMS maturity. Generally, 3 to 8 days on site per audit cycle, with an additional 2 to 4 weeks for analysis, grading findings and producing the formal report.
Yes. Audits of suppliers and strategic partners for initial qualification or annual requalification under P7 requirements. Technical and regulatory assessment with a formal opinion and a supplier-specific action plan.
Companies that discover gaps during the certification audit pay a high price: Grade 4 and 5 findings can suspend the certificate, delay market access and lead to field actions. Structured internal auditing anticipates the problem while there is still time to resolve it.
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