Combined Kit ISO 13485 + MDSAP

Combined Kit ISO 13485 + MDSAP — The Ultimate Global QMS Documentation Bundle

The complete documentation backbone for medical device manufacturers operating in multiple global markets. Combines our ISO 13485 QMS Kit with our MDSAP Documentation Kit into a single audit-ready package — covering ISO 13485:2016/A11:2021, EU MDR 2017/745, FDA QMSR (effective Feb 2026), and all 5 MDSAP jurisdictions (Brazil, Japan, Canada, Australia, USA).

What’s included:

• Quality Manual (QM-001) — top-level QMS document covering both ISO 13485 and MDSAP scope
• 41 Standard Operating Procedures — 4 Shared Core (Document Control, Management Review, Internal Audit, CAPA) + 26 ISO-specific (Risk, HR, KPI, CSV, NC, Change, Clinical, Vigilance, Complaint, UDI, Design Control, Process Validation, MDF, Customer, Strategy, Infrastructure, Supplier, Production, Incoming, Sterilization, FSCA, PMS, Usability, Labelling, Purchase, NB Change) + 11 MDSAP-specific (Program Management + 5 Marketing Authorization SOPs + 5 Vigilance Reporting SOPs across Brazil/Japan/Canada/Australia/USA)
• 70+ Templates — forms, plans, reports, registers, matrices, and decision worksheets ready to customize. Includes 23 pre-populated KPIs, 16 competence areas, 6 sample suppliers, 10 sample design inputs, jurisdiction-specific reportability worksheets, country-specific application checklists
• Master Tracker — single Excel workbook aggregating 7 operational logs (NC, CAPA, Complaint, Change Control, Vigilance/FSCA, Supplier Performance, Regulatory Submissions)
• Master Index — comprehensive Excel catalogue with 5 sheets: Overview, Foundation, ISO 13485 packages, MDSAP packages, and a 19-step Implementation Roadmap
• README + Implementation Roadmap — quick start guide with phase-by-phase rollout plan (Foundation → ISO 13485 → Internal Audits → MDSAP Markets → Audit Prep)

Why this kit: Operating in multiple global markets normally requires either two separate documentation projects or expensive consulting engagements. This kit delivers everything in a single deduplicated structure — Shared Core SOPs are placed once (not duplicated between ISO and MDSAP), so you customize each document once and it applies to both audit programs. Save €199 vs buying the ISO 13485 Kit (€499) and MDSAP Kit (€399) separately, and gain a truly integrated QMS foundation rather than two parallel systems.

Folder structure: The kit is organized into three logical sections:

• 00 – Shared Foundation — documents used by BOTH ISO 13485 and MDSAP audits (Quality Manual, Master Tracker, 4 Core SOPs)
• 01 – ISO 13485 Specific — 26 process packages covering EU MDR + FDA QMSR-specific requirements (Risk, Design, Production, Clinical, Regulatory, etc.)
• 02 – MDSAP Specific — 11 process packages covering jurisdiction-specific requirements (Brazil ANVISA, Japan PMDA, Canada Health Canada, Australia TGA, USA FDA)

Aligned with: ISO 13485:2016/A11:2021 · ISO 14971:2019/A11:2021 · EU MDR 2017/745 · FDA QMSR (21 CFR 820 effective 2026) · MDSAP Audit Companion v3.0 · ANVISA RDC 751/2022 · ANVISA RDC 67/2009 · Japan PMD Act + JMDN Classification · Health Canada SOR/98-282 · TGA TG (MD) Regulations 2002 · FDA 21 CFR Part 803 · IEC 62366-1 · IEC 62304 · IEC 60601 · ISO 10993 · ISO 11135/11137/17665 · ISO 11607 · MDCG guidance (2019-7, 2020-3, 2020-5, 2020-7/8, 2020-13, 2022-21, 2024-1) · FDA Process Validation 2011 · FDA HFE 2016

Who this is for: Medical device manufacturers preparing for global market entry, companies expanding from EU/USA into MDSAP markets, organizations seeking a single audit-ready documentation source for ISO 13485 + EU MDR + FDA QMSR + 5 MDSAP jurisdictions, regulatory consultants serving multi-market clients.

Format: Microsoft Word + Microsoft Excel (fully editable) — 122 files in organized package structure Updated: May 2026 — reflects EU MDR + FDA QMSR transition (Feb 2026), latest MDCG guidance, and current MDSAP market requirements Delivery: Instant download after purchase (single ZIP, ~2.2 MB)