From initial assessment to certificate maintenance: we integrate ANVISA, FDA, Health Canada, TGA and PMDA requirements within a single QMS architecture. A risk-based methodology aligned with ISO 13485:2016, ISO 14971:2019 and ISO 19011:2026.
MDSAP allows a single QMS audit to be recognised by the five international regulatory authorities participating in the programme. It reduces the audit burden, operational cost and time to market, while raising QMS maturity to a truly global standard.
Six complementary areas covering the MDSAP lifecycle: from initial assessment to continuing training for internal and lead auditors.
We act as a technical extension of Quality and Regulatory teams, with solutions tailored to QMS maturity, portfolio complexity and target markets.
We guide the client through every stage to audit readiness: structuring the QMS, interpreting the MDSAP Audit Approach (P1-P7) and preparing for certification by an Auditing Organisation recognised by the programme.
We apply the complete official MDSAP methodology, covering all seven processes, their tasks and linked items under ISO 19011:2026. Findings categorised by severity, with a structured action plan and CAPA.
Training delivered at the client's premises, using real scenarios from its operational context: products, critical processes, suppliers and audit history.
Advanced training for professionals who will coordinate audit teams and take responsibility for governance of the QMS audit programme.
An open-enrolment format, ideal for individuals or small teams seeking recognised MDSAP QMS auditing training. Immersion in a focused environment, with networking across companies.
MDSAP auditing is structured around seven interconnected processes. A thorough understanding of them distinguishes a QMS that passes from one with findings.
| ID | MDSAP Process | Regulatory scope |
|---|---|---|
| P1 | Management | Definition of policies, quality objectives, strategic planning and management review. |
| P2 | Device registration and listing | Meeting registration requirements for each applicable regulatory authority. |
| P3 | Measurement, analysis and improvement | Process monitoring, internal audits, data analysis and corrective actions. |
| P4 | Adverse events and recalls | Post-market surveillance, complaint handling and regulatory field actions. |
| P5 | Design and development | Design control from concept to production transfer, with risk management. |
| P6 | Production and service controls | Manufacturing process validation, traceability, identification and product control. |
| P7 | Purchasing | Supplier qualification, control of critical inputs and performance evaluation. |
We manage MDSAP consultancy from assessment to certificate maintenance, integrating the five regulatory authorities' requirements within a single QMS architecture.
Technical rigour, a structured approach and a pragmatic perspective. Short delivery cycles, clear governance and auditable milestones.
We apply ISO 13485:2016 and ISO 14971:2019 risk-based thinking to every decision: prioritising nonconformities, audit depth and remediation effort. Risk runs through product, process and system.
We do not treat requirements as an additional layer of paperwork. We redesign workflows, controls and evidence so regulatory compliance follows naturally from correct operations. This reduces compliance costs and removes weak points.
We measure success through concrete outcomes: fewer nonconformities, successful certification and recertification audits, certificate maintenance over multi-year cycles and readiness for unannounced audits.
Early assessment and structured gap remediation mitigate major nonconformities, field actions, sales suspensions and loss of certificates.
A truly multi-jurisdictional QMS, able to respond with equal robustness to ANVISA, FDA, Health Canada, TGA and PMDA requirements.
A model calibrated through practical experience in real audits. It increases the likelihood of successful certification and recertification, while reducing the number and severity of findings.
The MDSAP journey drives operational improvement: revealing inefficiencies, eliminating documentary rework, harmonising workflows and strengthening quality culture.
Questions we receive before starting MDSAP consultancy.
It depends on the maturity of the existing QMS. On average, 6 to 12 months from initial assessment to the certification audit by an Auditing Organisation, including documentation alignment, practical implementation, training and internal validation audits.
Yes. We provide consultancy for Class I to IV devices, including implantables, software as a medical device (SaMD), IVDs and combination products. Implementation depth is adjusted to product risk and market strategy.
It can be modular. We provide specific support as needed (gap analysis, Technical Files, ISO 14971, supplier qualification, mock audits), or manage the full project from assessment to certification. The scope depends on your current stage and internal capacity.
Both. For stages requiring physical presence (interviews, production walkthroughs, internal audits and mock audits), we work on site. Other areas - documentation design, critical review and theory training - work remotely without loss of quality.
Any Auditing Organisation recognised by the MDSAP programme (BSI, DEKRA, DQS, Intertek, NSF-ISR, SGS, TÜV Rheinland, TÜV SÜD, UL and others). Our implementation methodology is AO-agnostic and based on the official MDSAP Audit Approach document.
Companies that treat ANVISA, FDA, Health Canada, TGA and PMDA as separate projects spend 5 times more and face 5 audit cycles. MDSAP reduces this to a single architecture - but it only works if the QMS is designed for it from the outset.
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