Risk Management Toolkit: The ISO 14971 System That Actually Gets Used
Complete ISO 14971:2019 risk management file templates. Risk analysis, dFMEA, pFMEA, benefit-risk analysis, and production monitoring. FDA and EU MDR compliant.
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This toolkit is designed for teams facing these challenges:
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Frequently Asked Questions
What file formats are included?
All 8 templates are delivered in editable Microsoft Word (.docx) and Excel (.xlsx) formats. The Risk Analysis Worksheet and FMEA templates are Excel workbooks for easy scoring and filtering.
Which version of ISO 14971 does this cover?
ISO 14971:2019 (third edition) and ISO/TR 24971:2020 (implementation guidance). Templates reference 2019 clause numbers throughout.
Who is this for?
Any medical device manufacturer regardless of size or device class. Risk management is required for 510(k), EU MDR, and ISO 13485 certification. Particularly valuable for teams who've had risk files questioned by auditors or reviewers.
Does this cover software and SaMD risks?
Yes, with considerations for software risk integrated into the dFMEA and Risk Analysis templates. For full IEC 62304 software lifecycle documentation, pair with the SaMD Toolkit.
Does this work for EU MDR benefit-risk requirements?
Yes. The Benefit-Risk Analysis Template is structured per EU MDR Article 9 and Annex I General Safety and Performance Requirements. It satisfies both FDA and Notified Body reviewers.
How long does building a risk file take?
For a straightforward Class II device: 2-4 weeks for initial risk file creation. Ongoing maintenance is lighter — typically 1-2 days per design change or post-market signal.
Will I get updates when ISO 14971 is revised?
Yes — free updates by email when the standard is revised or when FDA/IMDRF guidance on risk management changes.
What's your refund policy?
7-day Audit-Ready Guarantee. Full refund if not satisfied — email support@regwatchdaily.com. No questions asked.
Can I integrate this with our existing design controls?
Yes. The Risk Control Measures Tracking links directly to design outputs, and the templates include guidance on connecting risk file references to your Design History File.
How does this compare to what a consultant would provide?
Identical structure to what top-tier regulatory consultants use. At $150-250/hour, a consultant-built risk file for a simple device runs $5,000-15,000. This toolkit is a fraction of that cost.
What file format are the templates in?
All templates are provided in editable Microsoft Word (.docx) format. You can customize them to match your company's branding and specific requirements.
How quickly will I receive the files?
Instantly. After purchase, you'll receive an email with download links within 2-3 minutes. Check your spam folder if you don't see it.
Can I use these for multiple projects or clients?
Yes. Your purchase includes a company-wide license. Use the templates across all your projects and devices within your organization.
Do these templates get updated when regulations change?
Yes. You'll receive free updates via email whenever we update templates for new guidance or regulatory changes.
What if I need help customizing the templates?
Email us at support@regwatchdaily.com. We typically respond within 24 hours with guidance on customization.
Is there a money-back guarantee?
Yes — the Audit-Ready Guarantee. If you're not satisfied within 7 days, email us for a full refund. No questions asked.
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