Quality management for medtech that actually works in practice

What it is

ISO 13485 is a quality management standard for organizations involved in medical devices. Unlike generic quality frameworks, it is laser-focused on the safety and performance of medical devices and Software as a Medical Device (SaMD), with a strong emphasis on documentation, strict traceability, and life-cycle risk management.

When to use it

Use this add-on when your organization develops, supplies, or supports medical devices or medical software, and needs to manage quality requirements in a structured, practical way. It is an absolute necessity for organizations aiming to achieve CE marking or comply with the stringent European Medical Device Regulation (MDR)↗️ without breaking into a cold sweat during audits.

What it adds

It extends your existing management system with medical-device-specific quality requirements covering everything from design and development to production, distribution, and post-market surveillance. Since quality and security are deeply intertwined in medtech, this add-on helps you seamlessly align your QMS and ISMS by providing:

• Step-by-step instructions on how to update an existing ISO 27001 and ISO 9001 implementation to comply with ISO 13485.
• A comprehensive mapping table, which is essential since the older chapter numbering of ISO 13485 does not natively match the current High-Level Structure used by ISO 27001 and ISO 9001.
• Maximum efficiency by reusing your existing ISO 27001 and ISO 9001 clauses wherever possible to prevent administrative duplicate work.
• 7 extra clauses entirely unique to the ISO 13485 standard (including clauses 4.2.2, 4.2.3, and 7.5.2 through 7.5.5 and 7.5.7).
• Clear impact indicators for each new clause, comparing them directly to your existing frameworks.
• All required sample documentation and medtech-specific implementation instructions.

Add-ons can be used together with Instant 27001 for Confluence or Microsoft 365 (ISOPlanner). Instructions for installation and implementation are provided.

Relevant for

• Medical device companies
• Software companies developing medical software
• Healthtech organizations
• Organizations preparing for CE or MDR-related requirements
• Suppliers in the medical device sector

Pricing

All prices are excluding applicable taxes and subscription fees for Confluence, Microsoft 365 or ISOPlanner.