Risk Management & ISO 14971

ISO 14971 Risk Management Systems & Linked ISO 13485 Tools

Risk management is not a side document. It is a core control system that should shape design decisions, process controls, post-market response, and product lifecycle oversight. This collection is built for medical device companies that need practical tools to establish, maintain, and defend risk management in line with ISO 14971 while keeping it properly linked to ISO 13485 processes.

These products help you build the structure behind a working risk file: hazard identification, risk analysis, risk evaluation, control measure selection, residual risk assessment, and post-production feedback. They also support the critical links between risk management and design controls, complaints, CAPA, and product change control.

What This Collection Covers

  • ISO 14971 risk management systems
  • Training products for risk management teams
  • Integrated products linking risk to design controls and CAPA
  • Residual risk and risk-benefit workflow support
  • Post-market feedback into risk file updates
  • Cross-functional implementation for QA/RA and development teams

Why This Matters

ISO 14971 requires an ongoing process for identifying hazards, evaluating associated risks, controlling them, and monitoring the effectiveness of those controls throughout the device lifecycle. It also expects risk management to be maintained with production and post-production information. ISO 13485 reinforces that risk-based control should be applied across appropriate QMS processes and within product realization.

Who This Collection Is For

  • Manufacturers building formal risk files
  • Development teams linking risk to clause 7.3 outputs
  • QA/RA professionals cleaning up weak risk documentation
  • Consultants implementing integrated ISO 13485 + ISO 14971 systems
  • Companies that need better traceability from complaint to risk update

Build a More Defensible Risk File

If your current risk documentation is thin, disconnected, or difficult to update when new issues arise, this collection gives you the tools to build a more controlled and auditable risk management process that supports the entire QMS.

Three ways to buy ISO 13485 templates

Start with the gap assessment, build the core system with the Starter Kit, or get every kit at once. Upgrade credits mean you never pay twice for the same kit.

Gap Assessment Workbook See where you stand before you commit $49View Gap Assessment WorkbookStarter Kit Core system: 6 kits for clauses 4 to 6 and 8 $249 $504View Starter KitBest valueComplete QMS Kit All 15 kits, including design, risk and production $449 $1,375View Complete QMS Kit
Gap assessment, 71 requirement areas with action plan
Quality manual and management review kit
Document control and records kit
CAPA and nonconformance kit
Internal audit kit
Training and competence kit (8 modules)
Design controls and DHF kit, ISO 14971 risk management file kit
Supplier control, production and traceability, equipment and calibration kits
Software validation, medical device file and labelling kits
Complaint handling, PMS and vigilance kit, plus the process validation IQ/OQ/PQ pack
Start-here roadmap to certification
Optional 60-minute onboarding call with the author
30-day money-back guarantee, instant download, one-organization licence, free updates for this edition

Prices in USD. Crossed-out prices are the combined price of the included items bought separately. Own a smaller kit already? Upgrade credits are listed on each product page. Still unsure? Which kit is right for me?

Instant downloadFiles by email within minutes
Fully editableWord, Excel, PowerPoint. No macros
30-day money-back guaranteeDoesn't fit your system? Full refund, no fuss
Free updatesRevised files sent free when the standard changes

Not sure which ISO 13485 kit you need?

Run the free ISO 13485 gap assessment to see where you stand, then compare the Starter Kit, the Complete Kit and the individual kits side by side.

Get the free gap assessmentCompare ISO 13485 kits