ISO 13485 toolkit
Master and comply with the core quality management standard for medical device companies.
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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:
Compliance checklist
Preparing for ISO 13485 certification guide
Audit readiness checklist for medical device companies
Ultimate guide to medical device design controls
Design controls: 6 principles for success
9 ways to improve product quality in medical device product development
Assembling 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
Risk management plan template
Access a ready-made two-page document template for an ISO 13485 risk management plan
Medical device quality management software datasheet