ISO 13485 (CE) add-on

Quality management for medtech that actually works in practice

ISO 13485 is the international standard for quality management systems in medical devices. It’s built to support organizations across the entire lifecycle, from design and development to production, distribution, and post-market surveillance. Unlike generic quality frameworks, ISO 13485 is laser-focused on the safety and performance of medical devices, with a strong emphasis on documentation, traceability, and risk management.

For companies aiming to place products on the European market, ISO 13485 is more than helpful. It is essential. It aligns closely with the requirements of the EU Medical Device Regulation (MDR) ↗️ and is a widely accepted route to meet the QMS requirements for CE marking. In other words, it’s not just about doing quality right. It’s about proving it to regulators and notified bodies without breaking into a cold sweat.

If you’re already using ISO 27001 to secure health-related data or connected devices, adding ISO 13485 completes the picture. With Instant 27001’s optional ISO 13485 add-on, you can align your QMS and ISMS in a way that is efficient, scalable, and fully audit-ready. Because in medtech, quality and security are not just boxes to tick. They are what keep patients safe and your business moving forward.

Benefits

• Contains instructions how to update an existing ISO 27001 + ISO 9001 implementation to comply to ISO 13485:2016
• Existing ISO 27001 / ISO 9001 clauses are reused where possible
• As the numbering of chapters in ISO 13485:2016 does not match that of the current high level structure, a useful mapping table is included
• 7 extra clauses unique to ISO 13485 (4.2.2, 4.2.3, 7.5.2 thru 7.5.5 and 7.5.7) are added
• For each of these, the impact is indicated as compared to ISO 27001 or ISO 9001
• Implementation instructions and sample documents are included

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

Pricing

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