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.

Compact flat illustration representing ISO 14971 medical device risk management, featuring a checklist, flowchart, monitor, and warning triangle in cool blue tones.

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