Full Medical Device QMS Kits — Ready to Implement
Complete ISO 13485, ISO 14971, MDR and FDA compliance toolkits, delivered in ready-to-use consultant-grade format.
- End-to-end compliance templates
- Fully editable files
- No recurring licence fees
- Structured for regulatory audits
Pricing Tiers
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QMS-in-a-Box Role Edition
View CollectionEnd-to-end ISO 13485 operating models built by regulatory role.
Each system defines scope, clause applicability, mandatory controls, audit exposure, and implementation order before documents are written. -
Execution Packs
View CollectionRole-locked execution tools that replace consultant judgement.
Each pack defines decisions, inputs, outputs, required records, and audit failure conditions for a specific role. -
Clause Toolkits
View CollectionClause-focused toolkits for buyers entering through audit findings or clause gaps.
Each toolkit isolates regulatory intent, required controls, mandatory records, audit tests, and major NC triggers for a specific clause or sub-clause. -
Starter Pack
View Starter Pack• Document Control System
• Change Control Log
• Basic ISO 14971 Risk Kit
• Training & Competence Kit
• Supplier Starter Tools -
Professional Pack
Most Popular• Everything in Starter
• CAPA & Nonconformance System
• Complaint Handling System
• Internal Audit Toolkit
• PMS & Vigilance Toolkit
• QMS Validation Pack (URS/IQ/OQ/PQ)
• Traceability & UDI Toolkit
• Design & Development System -
Complete Regulatory Suite
View Complete Suite• Everything in Professional
• MDR Technical Documentation System
• FDA QSR / 21 CFR 820 Documentation
• Sterilization & Sterile Barrier Validation Pack
• Records & Registers Master System
• Supplier Quality Agreement Pack
• Full SOP & Training Slide Library
Collapsible content
Document Control & Records Management
Master Document List, controlled SOPs/forms/registers, revision logs, training triggers and record retention architecture aligned to ISO 13485:2016.
Risk Management System (ISO 14971)
Hazard identification, hazardous situations, risk matrices, risk control templates and full Risk Management File structure aligned to ISO 14971.
Supplier Lifecycle System
Supplier qualification, ASL, monitoring and re-evaluation cycles, supplier scoring, and Quality Agreement shells.
Production & Service Controls
Incoming goods verification, status labelling, traceability, sterilization and special process validation, IQ/OQ/PQ equipment controls.
PMS & Vigilance
PMS plans, PMS report templates, trend analysis sheets, FSCA/FSN templates and complaint → CAPA → RMF integration.
Design & Development Control
Design plan, inputs, outputs, review minutes, verification and validation protocols, DHF index and traceability matrices.
Validation Packs
URS, Validation Plans, IQ/OQ/PQ protocols and reports with example entries and red instructional guidance for software, process and sterile validations.
Why Teams Choose These Kits Over Traditional Consulting
• No hourly fees or long timelines.
• Templates built directly from ISO 13485, ISO 14971, MDR and FDA structures.
• Audit-ready structure with clear clause mapping.
• Full editability to match your devices, processes and jurisdictions.
• One purchase secures a complete, scalable QMS architecture.
Frequently Asked Questions
Do these templates meet ISO 13485?
Yes. The architecture is mapped to ISO 13485:2016 clauses and documentation expectations. You still need to populate them with your own processes and evidence and implement the system.
Are the files fully editable?
Yes. You receive Word, Excel, PDF and PPTX files you can adapt to your organisation.
Are these suitable for MDR and FDA use?
The Complete Regulatory Suite includes MDR Technical Documentation structures and FDA QSR-aligned procedures and records. They are designed to support submissions and audits.
Will this be accepted by Notified Bodies and regulators?
The content follows regulatory and standard requirements and is structured for audit defensibility. Acceptance still depends on your implementation and data.
