Medical Device Software Procedure Bundle
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
- Digital Content - Instant Download
Medical Device Software Procedure BundleThe Medical Device Software Procedure Bundle includes procedures related to development of Software and SaMD products, validation of software, and software clinical evaluation.
Medical Device Software Procedure Bundle - ContentsThe 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. 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. 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. 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 Development Plan - The Software Development Plan addresses content contained within IEC 62304:2015, IEC 12207 and FDA Guidance. The Medical Device Software Development Plan helps the user to organize the necessary roadmap, phases and tasks required throughout the development lifecycle, regardless of which life cycle model or approach is employed. Medical Device Software Procedure Bundle - ComplianceThe 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 RELATED LINKS |
Software Procedure Bundle Contents
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Medical Device Quality Management System | DESIGN PLUS
The DESIGN PLUS Quality Management System (QMS) is configured for companies engaged in research and development of medical devices but perform no manufacturing (Specification Developers). The Design Plus QMS system is configured for companies desiring ISO 13485:2016 certification and FDA QSR compliance. Products installed in 46 countries and growing!
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Medical Device Quality Management System | MANUFACTURING PLUS
The Medical Device Quality Management System | MANUFACTURING PLUS System is our "top line" QMS product configured for companies engaged in the design and manufacture of medical devices seeking ISO 13485:2016 certification and FDA QSR compliance. Products installed in 46 countries and growing!
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