Pre-built template kits so you're not starting from a blank page. Designed to support compliance with ISO 13485 and related standards.
The ISO 13485 Starter Kit includes 30+ 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.
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.
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.
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.