Functional Safety Certification for Exoskeletons: ISO 13485 Explained

Date
2027-05-25
Location
Online
Host
Zach L

About this event

A Case-Study Review for Regulatory Affairs Specialists pursuing functional safety certification. A live 30-minute case-study review on ISO 13485 (Medical Device Quality Management) for exoskeletons, built for regulatory affairs specialists pursuing functional safety certification. What We'll Cover: What ISO 13485 (Medical Device Quality Management) requires and how its scope applies to exoskeletons Mapping ISO 13485 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 regulatory affairs specialists preparing for assessment Related topics: ISO 13485 · Exoskeletons · functional safety certification · functional safety assessment · Case-Study Review · Regulatory Affairs Specialists · safety lifecycle · compliance evidence · SIL · PL · risk assessment · safety case Critical Systems Analysis provides embedded functional safety consulting for ISO 13485. Learn more: https://criticalsystemsanalysis.com Partner with us: https://meetings.hubspot.com/benjamin-twombly/strategic-partnerships

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About ISO 13485 (Medical Device Quality Management)

This event covers the compliance, engineering, and verification requirements defined by ISO 13485.

ISO 13485 specifies quality management system requirements for medical device organizations across the lifecycle — design, production, distribution, servicing — harmonized to regulatory expectations (EU MDR, and the basis of MDSAP).

What it regulates

Design controls, risk-based QMS processes, supplier control, production and process validation (including software validation), traceability, complaint handling and vigilance feeding corrective action.

Who must comply

Legal manufacturers, contract manufacturers and key suppliers in medical supply chains; certification is a de facto market entry ticket.

Key requirements of ISO 13485

  • Design and development controls with design file
  • Process validation where output cannot be fully verified
  • Traceability and UDI-supporting records
  • CAPA, complaint handling, and regulatory reporting interfaces

Key concepts: ISO 13485

Design history linkage
Design inputs/outputs/verification/validation records proving the device was developed under control.
Process validation
Establishing by evidence that special processes (sterilization, welding, software builds) consistently produce conforming output.
Risk-based QMS
14971 thinking embedded into process controls, not just product design.

Frequently asked questions: ISO 13485

How do 13485 and 62304/14971 fit together?

13485 is the organizational shell: it mandates that design and risk activities happen under control; 14971 provides the risk method and 62304 the software lifecycle executed within that QMS.

Standard information based on the published text of ISO 13485 (Medical Device Quality Management). Event content is provided by the host. For authoritative guidance, consult the official standard body.