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Medical Device Software Procedure Bundle

SKU: MDSBNDL

$499.00

$499.00

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The Medical Device Software Procedure Bundle includes procedures related to development of SaMD products, validation of software, software clinical evaluation, and how to apply human factors and usability engineering to the medical device development process.

• ISO 13485:2016 Compliant
• FDA QSR Compliant
• ​MS Word Format
• ​Digital Content - Instant Download

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Medical Device Software Procedure Bundle

The Medical Device Software Procedure Bundle includes procedures related to development of SaMD products, validation of software, and how to apply human factors and usability engineering to the medical device development process.

Medical Device Software Procedure Bundle - Contents

The Medical Device Software Procedure Bundle includes the following procedures:

• Software as a Medical Device (SaMD) Development Procedure -The SaMD Development Procedure governs the planning and realization of Software as a Medical Device (SaMD) product lifecycle processes.

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• Software Validation Procedure -The Software Validation Procedure establishes the requirements for computer systems and software used in medical device development and production, and post-distribution QA activities to ensure they have been validated for their intended use.

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• ​Human Factors and Usability Engineering Procedure -The Human Factors Engineering (HFE) and Usability Engineering (UE) Procedure assists in following appropriate human factors and usability engineering processes to ensure new medical devices will be safe and effective for the intended uses and environments. ​

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• Software Clinical Evaluation Procedure -The Software as a Medical Device Clinical Evaluation Procedure governs the clinical evaluation activities, including the assessment and analysis of the clinical safety, effectiveness and performance. ​

Medical Device Software Procedure Bundle - Compliance

The Medical Device Software Procedure comply with ISO 13485:2016, IEC62304:2015, and 21 CFR Part 820.

​​For more information about our Medical Device Software Procedure Bundle product please contact us at info@aplyon.com 

Software Procedure Bundle Contents

Software Development

Usability Engineering

Software Validation

Clinical Evaluation

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Design Control Procedure Bundle
Risk Management Procedure Bundle
Clinical Evaluation Procedure Bundle
Complaint Handling Procedure Bundle
Medical Device Labeling Procedure Bundle
​Document Control Procedure Bundle
Cleanroom Procedure Bundle

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