Regulatory

IEC 62304 Medical Device Software and SaMD

IEC 62304 defines lifecycle processes for medical device software. Viltis supports software quality planning, documentation, safety classification alignment, and SaMD regulatory interfacing without cl…

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Practice areaRegulatory
Typical needCapability support for regulated programs
EngagementConsulting, augmentation, or hybrid
Related pathRegulatory

The client situation

When organizations typically need this capability.
  • New SaMD or embedded device software programs
  • Audit or submission gaps in software lifecycle evidence
  • Agile development needing regulatory mapping

How Viltis helps

Structured support, end to end

  1. 01

    Step 1

    Software classification support

  2. 02

    Step 2

    Lifecycle procedure design

  3. 03

    Step 3

    Traceability and verification planning

  4. 04

    Step 4

    SOUP and risk integration

IEC 62304 defines lifecycle processes for medical device software. Viltis supports software quality planning, documentation, safety classification alignment, and SaMD regulatory interfacing without claiming to certify software.

Typical deliverables

What engagement can produce

Software plan templates

Lifecycle gap assessments

Traceability frameworks

FAQ

Common questions

Does Viltis write all code documentation?

We typically embed with engineering and quality to produce compliant artifacts rather than replacing software teams.

Related proof

Manufacturing, Quality and Process Team

Recommissioning and qualifying a manufacturing site to produce COVID-19 test kits at scale.

Read the case study →

Viltis provides consulting and resourcing for compliance readiness and operational support. We do not issue certifications or act as an accredited certification body.

Need support with IEC 62304 Medical Device Software and SaMD?

Discuss this requirement with our team - scope, timeline, and delivery model.

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