Software as a Medical Device (SaMD) Development Procedure
SKU: SOP 7-043
The SaMD Development Procedure governs the planning and realization of Software as a Medical Device (SaMD) product lifecycle processes. The procedure provides instruction and guidance throughout the software lifecycle and establishes critical linkage to QMS and regulatory requirements.
- ISO 13485:2016 Compliant
- FDA QSR Compliant
- IEC 62304:2015 Compliant
- MS Word Format
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