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2 years ago
 

Medical Device Design Control (Part 3 of 3)

This entry is part 1 of 3 in the series Medical Device Design Control

Medical device product development work is a highly integrated, and regulated process. Implementation of a requirements tracking solution requires attention to a variety of nuanced topics. In this 3-part series, we present a practical approach derived from real-world experience developing medical devices using Polarion solutions. In this third and final installment, we look into Document Definition. (more…)

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2 years ago
 

Medical Device Design Control (Part 2 of 3)

This entry is part 2 of 3 in the series Medical Device Design Control

Medical device product development work is a highly integrated, and regulated process. Implementation of a requirements tracking solution requires attention to a variety of nuanced topics. In this 3-part series, we present a practical approach derived from real-world experience developing medical devices using Polarion solutions. In this second installment , we look into traceability, Design V&V and Risk Management. (more…)

by
2 years ago
 

Medical Device Design Control (Part 1 of 3)

This entry is part 3 of 3 in the series Medical Device Design Control

Medical device product development work is a highly integrated, and regulated process. Implementation of a requirements tracking solution requires attention to a variety of nuanced topics. In this 3-part series, we’ll present a practical approach derived from real-world experience developing medical devices using Polarion solutions. (more…)