ISO toolkit

ISO 13485:2016 Medical Devices QMS Toolkit

QMS documentation for medical device manufacturers

A complete quality management system for ISO 13485:2016 compliance, covering design controls, risk management, supplier management and regulatory records for medical device organizations.

What's inside

• Quality manual and management procedures
• Design and development DMR/DHF templates
• Risk management file aligned to ISO 14971
• CAPA, complaints and vigilance process
• Supplier qualification and audit pack