ISO 13485
MDSAP
We help medical device companies achieve and maintain MDSAP compliance through structured, audit-ready support tailored to your organization. Our services include MDSAP gap analysis, quality management system alignment to ISO 13485 and participating regulatory requirements, process mapping to the MDSAP audit model, documentation remediation, internal audit support, and audit preparation with hands-on guidance. By simplifying complex requirements and focusing on effective implementation, we enable you to pass MDSAP audits with confidence while strengthening global regulatory readiness across key markets.
TTAIN Publications on MDSAP:
Top Ten Award International Network (often abbreviated TTAIN) has published a series of Medical Device Single Audit Program (MDSAP)-focused books authored by Jahangir Asadi and others that aim to break down the ISO 13485:2016 requirements and how they apply in different countries for employees, employers, and quality professionals; these include multi-volume guides such as MDSAP Vol. 1 of 5 Australia: ISO 13485:2016… and MDSAP Vol. 3 of 5 Canada: ISO 13485:2016…with straightforward explanations of MDSAP quality management system expectations. TTAIN’s publications are typically designed to help people at various levels of an organization understand and implement MDSAP and related standards across international contexts.
All of the books also include a full, complete applicational checklist, enabling user-friendly, step-by-step actions for effective implementation and compliance.
Australia
MDSAP
Brazil
MDSAP
Canada
MDSAP
Japan
MDSAP
USA
MDSAP