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- Software as a Medical Device (SaMD) Development Procedure
Software as a Medical Device (SaMD) Development Procedure
$149.00
$149.00
Unavailable
per item
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
- Digital Content - Instant Download
SKU:
SOP 7-043
Software as a Medical Device (SaMD) Development ProcedureThe SaMD Development Procedure governs the planning and realization of Software as a Medical Device (SaMD) product lifecycle processes.
SaMD Development Procedure OverviewThe Software as a Medical Device (SaMD) Procedure includes detailed guidance on the following:
SaMD Development Procedure ComplianceThe Software as a Medical Device Development Procedure is IEC 62304:2015, ISO 13485:2016, and 21 CFR Part 820 compliant.
For more information about our Software as a Medical Device (SaMD) Development Procedure contact us at [email protected] RELATED LINKS |
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Medical Device Software Development Plan
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The Medical Device Software Development Plan provides detailed instruction on the creation of a software development plan that is harmonized with the requirements of IEC 62304 and FDA guidance.
- IEC 62304:2015 Compliant
- ISO 13485:2016 Compliant
- FDA QSR Compliant
- MS Word Format
- Instructive Document
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Software Validation Procedure | ISO 13485 | FDA QSR Compliant
$149.00
The Software Validation Procedure governs computer systems and medical device software used in medical device development, production and QA activities. The procedure includes a detailed validation protocol with step by step instruction for conducting the validation and generating a validation report.
- ISO 13485:2016 Compliant
- FDA QSR Compliant
- MS Word Format
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Medical Device Software Procedure Bundle
$449.00
The Medical Device Software Procedure Bundle includes procedures related to development of software products, validation of software, software clinical evaluation, and how to apply human factors and usability engineering to the medical device development process. Also includes Medical Device Software Development Plan.
- ISO 13485:2016 Compliant
- FDA QSR Compliant
- MS Word Format
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Software Clinical Evaluation Procedure
$149.00
The Software Clinical Evaluation Procedure governs the clinical evaluation activities, including the assessment and analysis of the clinical safety, effectiveness and performance, of the Software.
- ISO 13485:2016 Compliant
- FDA QSR Compliant
- MDR (EU) 2017/745 Compliant
- MS Word Format
- Digital Content - Instant Download