ISO 13485 Medical Device QMS Full Compliance Kit
The complete ISO 13485 document library. 157 professionally written templates organized across 21 QMS process areas — from design controls and production through PMCF, vigilance, and regulatory alignment.
Quality Manual, Policy, Objectives
Template document
Management Commitment and Review
Template document
Organizational Structure and Process Map
Template document
+ 2 more templates
Complete document set
What's included
Everything you need to build a complete compliance documentation set.
- Quality Manual, Policy, Objectives
- Management Commitment and Review
- Organizational Structure and Process Map
- Outsourced Processes and Supplier Oversight
- Document Hierarchy and Glossary
- Document and Record Control Procedure
- Master Document List and Procedures
- Document Approval Log and Retention Periods
- Audit Procedure, Programme, Schedule
- Audit Plan, Report, Findings, Follow-up
- CAPA Procedure, Register, Investigation
- Corrective and Preventive Action
- Effectiveness Review and CAPA Form
- Nonconforming Product Control and NC Log
- Change Control Procedure
- Change Request Log
- Impact Assessment
- Change Implementation Record
- Product Realization Planning
- Design Inputs/Outputs, Reviews
- Verification, Validation, Transfer
- Changes and DHF
- Risk Management Plan
- Purchasing Control Procedure
- Supplier Evaluation and Qualified List
- Supplier Reassessment and Purchasing Data
- Incoming Inspection
- Production Control
- Process Validation and IQ/OQ/PQ
- Validation Reports
- Sterilization, Sterile Barrier
- Implantable Device Tracking
- PMS Procedure, Plan, Report
- Trend Analysis
- PMCF Procedure, Plan, Report
- Clinical Evaluation Procedure
- Clinical Evaluation Report Template
- Literature Review
- Risk Management Procedure
- Risk Analysis, Evaluation, Control
- Hazard Log
- Risk Management Report (ISO 14971 aligned)
- Software Development Lifecycle
- Requirements, Architecture, Design
- Testing and Release (IEC 62304 aligned)
- Usability Engineering Procedure
- Use Specification
- User Interface Analysis (IEC 62366-1 aligned)
Is this right for you?
We believe in being upfront. Here's who this pack works best for.
- Medical device manufacturers implementing ISO 13485:2016 for certification or renewal
- QA/RA leaders building a complete, audit-ready QMS with no significant gaps
- Organizations scaling for MDR/IVDR alongside ISO 13485 compliance
- Multi-product or multi-site teams needing comprehensive documentation
- Organizations only needing mandatory documentation
- Teams with simple products and straightforward processes
- Those unfamiliar with ISO 13485 requirements
Why teams choose this pack
Practical benefits without the hype. Here is what you actually get.
Clarity from the start
No more staring at blank documents. Each template shows you what belongs where and why it matters.
Hours saved on structure
Skip the research phase. Start with proven layouts that align with regulatory expectations.
A path to follow
The included guides give you a practical sequence so you know what to tackle first.
Foundation to build on
These templates grow with you. Adapt them as your compliance program matures.
Questions about this product
Common questions specific to this template kit.
Ready to get started?
Skip the blank-page anxiety. Start with structure that aligns with ISO 13485 and adapt it to your context.
Instant download. Free updates. Single organization license.