ISO 14971 Risk Management Consulting for Medical Device Companies
Proactive risk management is essential to the success of any medical device company. ISO 14971:2019 provides the globally recognized framework for identifying, evaluating, controlling, and monitoring risks throughout the product lifecycle. At Wintersmith Advisory, we help you embed robust, compliant risk processes into your Quality Management System (QMS), accelerating market access and improving patient safety.
Why ISO 14971 Matters
ISO 14971 is the harmonized risk management standard required by regulators around the world. It underpins compliance with:
EU Medical Device Regulation (EU MDR 2017/745)
In Vitro Diagnostic Regulation (IVDR)
U.S. FDA 21 CFR Part 820 (Quality System Regulation)
ISO 13485:2016 (Medical Device QMS)
MDSAP and global notified bodies
Whether you're preparing a design dossier, addressing CAPAs, or undergoing an audit, effective risk management is non-negotiable.
Our ISO 14971 Consulting Services
1. Risk Management File (RMF) Creation
Complete documentation for ISO 14971 compliance
Hazard identification, risk estimation, and benefit-risk analysis
Risk control measures and residual risk evaluations
2. Process Integration with ISO 13485 & QMS
Align risk management with product development and QMS procedures
Support for design inputs, verification/validation, and post-market feedback
3. FMEA / Fault Tree Analysis (FTA) Workshops
Design and process FMEA facilitation
Hazard analysis using ISO 14971 principles
Risk traceability from design to end-of-life
4. Audit Readiness & Gap Assessments
ISO 14971 gap reviews and remediation plans
Preparation for notified body and FDA inspections
Integration with technical documentation and GSPR (General Safety and Performance Requirements)
5. Training & Capacity Building
Practical, role-specific ISO 14971 training
Support for cross-functional teams (RA, QA, Engineering, PM)
Templates, checklists, and decision-tree tools
Who We Work With
Medical device startups and scale-ups
Class I, II, and III manufacturers
Contract design & development organizations (CDDOs)
Companies preparing for EU MDR or FDA submission
Why Choose Wintersmith Advisory?
Regulatory Alignment: Deep expertise across ISO 14971, ISO 13485, FDA QSR, and MDR
Practical Guidance: Actionable, tailored support—not just theory
Flexible Delivery: On-site or remote consulting, training, and documentation
Audit-Proven: Clients consistently pass audits with robust, defensible RMFs
Related Services
ISO 13485 Implementation
EU MDR Compliance & GSPR Mapping
FDA QSR (21 CFR Part 820) Remediation
Design Controls & Technical Documentation
Medical Device QMS Consulting
Take Control of Risk—Start Today
Position your team for regulatory success. Let’s build an ISO 14971-compliant risk management system that supports innovation, compliance, and safety.
Contact us for a customized proposal.
Contact us.
info@wintersmithadvisory.com
(801) 558-3928