Functional Safety Certification for Surgical Robots: IEC 62304 Explained

Date
2026-12-07
Location
Online
Host
Zach L

About this event

A Lunch-and-Learn for Early-Career Engineers pursuing functional safety certification. A live 30-minute lunch-and-learn on IEC 62304 (Medical Device Software) for surgical robots, built for early-career engineers pursuing functional safety certification. What We'll Cover: What IEC 62304 (Medical Device Software) requires and how its scope applies to surgical robots Mapping IEC 62304 clauses to the certification evidence assessors expect System-specific hazards and safety functions typical of surgical robots Common findings that delay certification, and how to avoid them A practical readiness roadmap for early-career engineers preparing for assessment Related topics: IEC 62304 · Surgical Robots · functional safety certification · functional safety assessment · Lunch-and-Learn · Early-Career Engineers · safety lifecycle · compliance evidence · SIL · PL · risk assessment · safety case Critical Systems Analysis provides embedded functional safety consulting for IEC 62304. Learn more: https://criticalsystemsanalysis.com Partner with us: https://meetings.hubspot.com/benjamin-twombly/strategic-partnerships

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About IEC 62304 (Medical Device Software)

This event covers the compliance, engineering, and verification requirements defined by IEC 62304.

IEC 62304 defines the software lifecycle for medical device software: planning, requirements, architecture, implementation, verification, release and maintenance, scaled by software safety classes A/B/C based on possible harm.

What it regulates

Class-dependent rigor of development and maintenance processes, SOUP (software of unknown provenance) management, problem resolution, and the risk-management linkage to ISO 14971.

Who must comply

Medical device manufacturers and SaMD (software as a medical device) developers under FDA/EU MDR regimes, which recognize 62304 conformity.

Key requirements of IEC 62304

  • Safety classification A (no injury) / B (non-serious) / C (death or serious injury possible)
  • Development process activities per class
  • SOUP identification, requirements and anomaly evaluation
  • Maintenance and problem resolution processes

Key concepts: IEC 62304

Software safety class
Harm-based rigor scaling determined with risk controls considered.
Segregation
Architectural separation letting different classes coexist with justified independence.
SOUP
Third-party/OTS software whose behavior must be bounded by requirements and risk analysis.

Frequently asked questions: IEC 62304

How does 62304 interact with ISO 14971?

14971 owns hazard identification and risk control; 62304 consumes those controls as software requirements and returns implementation/verification evidence — the class assignment itself derives from 14971 analysis.

Standard information based on the published text of IEC 62304 (Medical Device Software). Event content is provided by the host. For authoritative guidance, consult the official standard body.