ISO 13485 toolkit

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

Complete the form to the right to get started!


What you'll get

1. Compliance checklist
Follow an in-depth, clause-by-clause checklist to ensure you meet every single ISO 13485 requirement

2. Preparing for ISO 13485 certification guide
Access top compliance tips, busted myths, the most common mistakes found by auditors and more

3. Audit readiness checklist for medical device companies
Make your next medical device audit painless and stress-free by becoming 100% audit-ready

4. Ultimate guide to medical device design controls
Become a design controls expert with our comprehensive guide. Know your DHF from your DMR


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

6. 9 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

7. Medical device quality management software datasheet
Learn how real medical device professionals use Qualio for a robust, holistic and compliant quality management system


ISO 13485 compliance toolkit