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iso-regulatory-requirements

ISO Regulatory Requirements for Medical Devices

isoregulatoryrequirements
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# ISO Regulatory Requirements for Medical Devices

Key ISO standards applicable to medical device development, quality management, and regulatory compliance.

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## Table of Contents

- [ISO 13485 Quality Management](#iso-13485-quality-management)
- [ISO 14971 Risk Management](#iso-14971-risk-management)
- [ISO 10993 Biocompatibility](#iso-10993-biocompatibility)
- [IEC 62304 Software Lifecycle](#iec-62304-software-lifecycle)
- [IEC 62366 Usability Engineering](#iec-62366-usability-engineering
How to Use

Recommended: Install to project (local)

mkdir -p .claude/skills
curl -o .claude/skills/iso-regulatory-requirements.md \
  https://raw.githubusercontent.com/alirezarezvani/claude-skills/main/ra-qm-team/regulatory-affairs-head/references/iso-regulatory-requirements.md

Skill is scoped to this project only. Add .claude/skills/ to your .gitignoreif you don't want to commit it.

Alternative: Clone full repo

git clone https://github.com/alirezarezvani/claude-skills

Then reference at ra-qm-team/regulatory-affairs-head/references/iso-regulatory-requirements.md

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