Traditionally, to achieve IEC 62304 compliance, you would labor through mountains of paper documents and disparate digital information, or invest in costly Document Management Systems. With Polarion, you can create any reports and export them at any point in time, including forensic level traceability, to satisfy any audit.
Michael Dalpiaz | Sirona Dental Systems
“Sirona Dental Systems uses Polarion to achieve compliance with medical device regulations like FDA or IEC 62304.”
Rafi Heumann | LifeWatch COO
"Polarion provides the foundation for submitting for FDA Clearance"
Software Lifecycle Process Template: IEC 62304 >
Quality System (QS) Regulation/Current Good >
Manufacturing Practices (CGMP) Template: FDA 21 CFR Part 820 >
Electronic Records/Signatures Template: FDA 21 CFR Part 11 >
Benefit/Risk Determination Template: ISO 14971 >
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