Compliance packs

Pre-built template kits so you're not starting from a blank page. Designed to support compliance with ISO 13485 and related standards.

ISO 13485 Starter Kit

The ISO 13485 Starter Kit includes 52 document templates covering the core requirements of the standard. Each template is pre-formatted with the right sections, headers, and placeholders — just fill in the content that's specific to your organization.

What's included

Quality Manual

Quality Policy

Management Review Procedure

Document Control Procedure

Record Control Procedure

Training Procedure

Design & Development Procedure

Risk Management Procedure

Purchasing & Supplier Control

Production & Service Controls

CAPA Procedure

Internal Audit Procedure

Complaint Handling Procedure

Nonconforming Product Procedure

Corrective Action Form

Preventive Action Form

Change Request Form

Supplier Evaluation Form

Management Review Minutes Template

Gap Analysis Checklist

How compliance packs work

When you activate a compliance pack, ArvoDocs creates all the included templates in your workspace as draft documents. Each template includes guidance notes explaining what to write in each section.

Templates are starting points — not rigid forms. Customize them to fit your processes, add or remove sections as needed, and use them as the foundation for your quality system.

Compliance packs also include pre-configured approval workflows and document numbering schemas that align with the standard's structure.

A note on compliance

Compliance packs are designed to support your compliance efforts — they are not a guarantee of compliance with any standard or regulation. Your quality system needs to reflect your actual processes, products, and regulatory requirements. We recommend working with a qualified consultant or regulatory professional when implementing your QMS.

Availability

The ISO 13485 Starter Kit is available on the Scaling and Enterprise plans. Additional compliance packs (ISO 9001, ISO 14971, IEC 62304) are on our roadmap.