ISO 13485 toolkit


Master and comply with the core quality management standard for medical device companies.

Instant access. No email required.


ISO 13485 is the definitive quality standard for organizations involved in the design, development and manufacture of medical devices.


Download our ISO 13485 toolkit to:


  • Get to grips with the requirements of the standard and what you need to do to comply


  • Start taking actionable steps towards robust and long-term ISO 13485 compliance


  • Become completely audit-ready and bring a safe, high-quality device to market


What you'll get:


  • Check-bgCompliance checklist
Follow an in-depth, clause-by-clause checklist to ensure you meet every single ISO 13485 requirement

  • Ticket-bgPreparing for ISO 13485 certification guide
Access top compliance tips, busted myths, the most common mistakes found by auditors and more

  • Subttasks-bgAudit readiness checklist for medical device companies
Make your next medical device audit painless and stress-free by becoming 100% audit-ready

  • Group-bgUltimate guide to medical device design controls
Become a design controls expert with our comprehensive guide. Know your DHF from your DMR


  • Key-bgDesign controls: 6 principles for success
Design controls were developed in FDA 21 CFR 820.30, and now form a crucial component of ISO 13485 Clause 7.3. Learn the 6 things you need to do for effective and robust design controls


  • BPM-bg9 ways to improve product quality in medical device product development
Dive into the 9 core actions you should take now for a competitive, accelerated and quality-centric route to market



  • Pencil-bgAssembling a Design History File (DHF) for your medical device

Know your DHF from your DMR? Need a rundown of the key ingredients of a Design History File? Our walkthrough guide runs you through everything you need to know


  • List-bgRisk management plan template

Access a ready-made two-page document template for an ISO 13485 risk management plan


  • Laptop-bgMedical device quality management software datasheet
Learn how real medical device professionals use Qualio for a robust, holistic and compliant quality management system