iso-13485-certification

Comprehensive toolkit for preparing ISO 13485 certification documentation for medical device Quality Management Systems. Use when users need help with ISO 13485 QMS documentation, including (1) conducting gap analysis of existing documentation, (2) creating Quality Manuals, (3) developing required procedures and work instructions, (4) preparing Medical Device Files, (5) understanding ISO 13485 requirements, or (6) identifying missing documentation for medical device certification. Also use when users mention medical device regulations, QMS certification, FDA QMSR, EU MDR, or need help with quality system documentation.

Install with Tessl CLI

npx tessl i github:K-Dense-AI/claude-scientific-skills --skill iso-13485-certification

What are skills?

1.45x

Quality

71%

Does it follow best practices?

Impact

93%

1.45x

Average score across 3 eval scenarios

Optimize this skill with Tessl

npx tessl skill review --optimize ./scientific-skills/iso-13485-certification/SKILL.md

SKILL.md

Review

Evals

Evaluation results

97%

42%

QMS Documentation Gap Assessment for MedPulse Diagnostics

Gap analysis workflow

Criteria

Without context

With context

Script invocation

80%

Correct --docs-dir argument

100%

Output file named gap-report.json

100%

gap-report.json file exists

100%

Compliance percentage reported

100%

Identifies present procedures

100%

Identifies missing procedures

100%

Prioritized action plan

100%

Quality Manual identified as gap

100%

Without context: $0.3651 · 2m 9s · 11 turns · 16 in / 8,744 out tokens

With context: $0.7149 · 1m 57s · 28 turns · 5,813 in / 6,755 out tokens

93%

40%

Quality Manual for Vertex Surgical Instruments

Quality Manual creation

Criteria

Without context

With context

Uses template structure

37%

100%

Section 0 present

40%

100%

Section 2.4 exclusion present

25%

100%

Exclusion justification quality

91%

100%

Quality Policy signed

50%

100%

Appendix A - 31 procedures

83%

Appendix C - process map

100%

No unreplaced placeholders

80%

50%

Organization-specific language

87%

100%

Documentation structure defined

62%

100%

Sections 4-8 address each clause

100%

Org chart or structure described

60%

100%

Without context: $0.5695 · 3m 51s · 18 turns · 24 in / 11,773 out tokens

With context: $1.4089 · 6m 1s · 23 turns · 7,348 in / 19,497 out tokens

91%

Corrective and Preventive Action Procedure for NovaBio Medical

CAPA procedure development

Criteria

Without context

With context

Uses template structure

80%

100%

Purpose section present

100%

Scope section present

100%

Definitions section present

100%

Responsibilities by role

100%

Procedure defines WHAT not HOW

90%

80%

Records section present

100%

References section present

80%

100%

CAPA request form created

62%

87%

RCA worksheet created

62%

Action plan template created

62%

Effectiveness verification checklist created

62%

100%

ISO 13485 clause references

100%

Without context: $0.4865 · 2m 33s · 22 turns · 28 in / 8,927 out tokens

With context: $1.0207 · 3m 52s · 28 turns · 33 in / 13,451 out tokens

Evaluated: 3 days ago
Agent: Claude Code
Model: Claude Sonnet 4.6

Table of Contents

QMS Documentation Gap Assessment for MedPulse Diagnostics Quality Manual for Vertex Surgical Instruments Corrective and Preventive Action Procedure for NovaBio Medical

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