Substituting paper records and handwritten signatures with electronic records and electronic signatures is a must for medical device manufacturers to achieve fast compliance with FDA 21 CFR Part 11. With Polarion's template you can exceed the requirement out-of-the-box.
Learn how existing customers enjoy the benefits of application lifecycle management (ALM) and discover how electronic records are maintained, tracked, and managed throughout their lifecycle.
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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