ISO 13485 toolkit for QARA professionals

Why download?

ISO 13485 compliance is the cornerstone of quality in the medical device industry. But getting it right can feel overwhelming. This toolkit pulls together expert resources, checklists, and templates so you can streamline compliance, improve audit readiness, and accelerate product development.

This ISO 13485 toolkit includes:

• 10 ways to improve medical device quality assurance today
• ISO 13485 audit preparation success guide 
• ISO 13485 audit checklist to guide your audits step by step
• The ultimate guide to design controls in the medical device industry
• A practical handbook on how to bring a medical device to market
• A guide on why Scilife is the smarter choice for ISO 13485 QMS software 
• Use case of Scilife’s design control software in action 
• A template to craft the perfect quality plan