Components of the Medical Device Software and SAMD Compliance
What are the Components of the Medical Device Software and SAMD Compliance? • The compliance of Medical Device Software and SAMD stand on three legs of regulations and standards. • The first two legs in the compliance structure are the Quality Management and Risk Management. • The third leg we need to consider is the software Development Management. • For devices without any software component, the Quality and Risk management practices area applicable to product lifecycle management (PLM).
What Regulations, Standards, Guidelines Apply to Medical Device Software and SAMD?
How Quality and Risk Management Processes Work for Medical Device Software and SAMD?
How to Define Traceability for Medical Device Software and SAMD There are many different objects and items are being created, tracked, managed, and processed as part of QMS, Risk and Agile management processes in a Medical Device Software development project. What will be the best way to answer the following questions: • How are they related to each other? • Which other items get impacted if we change one? • Which items fell through the crack? • In case of an issue, how to do the root-cause analysis?
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