Functional Safety Certification for Exoskeletons: ISO 14971 Explained

Date
2027-06-14
Location
Online
Host
Zach L

About this event

A Lunch-and-Learn for Cross-Functional Product Teams pursuing functional safety certification. A live 30-minute lunch-and-learn on ISO 14971 (Medical Device Risk Management) for exoskeletons, built for cross-functional product teams pursuing functional safety certification. What We'll Cover: What ISO 14971 (Medical Device Risk Management) requires and how its scope applies to exoskeletons Mapping ISO 14971 clauses to the certification evidence assessors expect System-specific hazards and safety functions typical of exoskeletons Common findings that delay certification, and how to avoid them A practical readiness roadmap for cross-functional product teams preparing for assessment Related topics: ISO 14971 · Exoskeletons · functional safety certification · functional safety assessment · Lunch-and-Learn · Cross-Functional Product Teams · safety lifecycle · compliance evidence · SIL · PL · risk assessment · safety case Critical Systems Analysis provides embedded functional safety consulting for ISO 14971. Learn more: https://criticalsystemsanalysis.com Partner with us: https://meetings.hubspot.com/benjamin-twombly/strategic-partnerships

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About ISO 14971 (Medical Device Risk Management)

This event covers the compliance, engineering, and verification requirements defined by ISO 14971.

ISO 14971 is the risk management standard for medical devices: a lifecycle process to identify hazards, estimate and evaluate risks, implement controls, and monitor production/post-production information — the hub all medical device standards reference.

What it regulates

Risk management planning and file, hazard identification, risk estimation/acceptability policy, control option hierarchy, residual risk and benefit-risk analysis, and post-market feedback loops.

Who must comply

All medical device manufacturers under MDR/FDA; auditors treat the risk file as the device's safety backbone.

Key requirements of ISO 14971

  • Risk management plan and file
  • Hazard/hazardous situation/harm chains with P1×P2 probability structure
  • Control hierarchy: inherent safety, protective measures, information
  • Overall residual risk and benefit-risk determination
  • Production and post-production monitoring

Key concepts: ISO 14971

Benefit-risk analysis
Justification when individual or overall residual risk is not outright acceptable.
Hazardous situation
Exposure of people to a hazard — the pivot between hazard and harm in estimation.
State of the art
The MDR-emphasized benchmark for acceptability criteria.

Frequently asked questions: ISO 14971

How does 14971 differ from 12100 thinking?

Structure is similar (identify, estimate, control, iterate) but 14971 adds clinical benefit-risk weighing and mandatory post-production feedback — medical risk acceptability can invoke therapeutic benefit, unlike machinery.

Standard information based on the published text of ISO 14971 (Medical Device Risk Management). Event content is provided by the host. For authoritative guidance, consult the official standard body.