€200

IEC 62304 Templates Bundle

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15 Files

A complete set of 14 editable templates covering every IEC 62304 lifecycle phase, aligned with EU MDR requirements. Includes all key documents from development planning and requirements to testing, release, maintenance, and problem resolution ready to integrate into your QMS and accelerate compliant software documentation.

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SOP - 00 SW lifecycle IEC 62366_SOP_EUMDR.docx

6.82 MB

SOFT-1 SW Development Plan_EUMDR.docx

93.4 KB

SOFT-2 SW Configuration Management Plan_EUMDR.docx

182 KB

SOFT-3 SW Requirements Specifications SRS_EUMDR.docx

86.9 KB

SOFT-4 System Architecture Description_EUMDR.docx

1.18 MB

SOFT-5 SW Detailed Design_EUMDR.docx

373 KB

SOFT-6 Traceability Matrix_EUMDR.xlsx

71.3 KB

SOFT-7 Design Review Document_EUMDR.docx

51.9 KB

SOFT-8 SW Test Plan_EUMDR.docx

54.4 KB

SOFT-9 SW Test Description_EUMDR.docx

55.3 KB

SOFT-10 SW Test Report_EUMDR.docx

44.6 KB

SOFT-11 SW Release note_EUMDR.docx

56.9 KB

SOFT-12 SW Maintenance Plan_EUMDR.docx

39 KB

SOFT-13 SW Problem Report_EUMDR.docx

34.2 KB

Guidance for software development_EUMDR.pdf

970 KB