Components of the Medical Device Software and SAMD Compliance

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Components of the Medical Device Software and
SAMD Compliance
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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).

3
What Regulations, Standards, Guidelines Apply to
Medical Device Software and SAMD?
4
How Quality and Risk Management Processes Work
for Medical Device Software and SAMD?
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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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Thank You
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