What To Know
The purpose of ISO 13485 medical device design controls is simple: to prove to regulators that your medical device is safe and serves its intended use. Design controls define your quality practices and procedures and prove the effectiveness of your development process.
The ISO medical device design control guidelines include ten areas of documentation. Your medical device needs each one in place as you develop your product. ISO 13485:2016 Section 7.3 aligns with the FDA's criteria for US approval, and supports EU and Health Canada guidelines.
How We Can Help
Experience and advanced knowledge are essential to regulatory approval and early success for your medical device. I3 Infotek has experienced quality engineers who specialize in preparing medical device design controls. We can support your in-house team through each standard listed in ISO 13485 Section 7.3, Design and development:
- Control of changes
- Files/Design history (DHF)