Created Usability File, Risk Management File and Software Development Technical File for IEC 60601-1 3rd Edition submission
Challenge
Customer needed documentation updated and/or created and submission package pulled together for IEC 60601-1 3rd Edition submission.
Actions
- Updated and/or created documents for Usability File compliant with IEC 60601-1-6 and IEC 62366.
- Updated and/or created documents for Risk Management File compliant with ISO 14971.
- Updated documents for Software Development Technical File compliant with IEC 60601-1-4 and IEC 62304.
- Assembled IEC 60601-1 3rd Edition submission package and completed submission forms for Notified Body.
Result
Customer received Certification to IEC 60601-1 3rd Edition for their product and the Usability File, Risk Management File and Software Development Technical File were 100% compliant with IEC 60601-1 3rd Edition with no changes required.