Change Control Process
CommunityManage software changes safely.
Legal & Compliance#software development#risk management#regulatory compliance#medical device#IEC 62304#change control
AuthorAminAlam
Version1.0.0
Installs0
System Documentation
What problem does it solve?
This Skill establishes a structured and compliant process for managing changes to regulated medical device software, ensuring safety, quality, and traceability.
Core Features & Use Cases
- Controlled Change Lifecycle: Manages the entire process from request to verification.
- Impact Analysis: Assesses the effects of changes on safety, cybersecurity, and regulatory submissions.
- Traceability: Links changes to requirements, risks, and code artifacts.
- Use Case: When a bug is found in a Class C medical device's firmware, this Skill guides the engineer through documenting the fix, analyzing its impact on patient safety and regulatory compliance, obtaining necessary approvals, and verifying the fix through regression testing.
Quick Start
Use the change control skill to document a new software change request for a critical bug fix.
Dependency Matrix
Required Modules
None requiredComponents
references
💻 Claude Code Installation
Recommended: Let Claude install automatically. Simply copy and paste the text below to Claude Code.
Please help me install this Skill: Name: Change Control Process Download link: https://github.com/AminAlam/meddev-agent-skills/archive/main.zip#change-control-process Please download this .zip file, extract it, and install it in the .claude/skills/ directory.
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