Design and Development Process Bundle
This Design and Development Bundle contains five of our SOPs at a 20% discount.
Bundle includes
Here are all the products that are included in your bundle.
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All Products
SYS-008: Design Control Procedure
CourseThis procedure package includes the training webinar and the following documents: 1) SYS-008, 2) FRM-018, 3) FRM-019, 4) TMP-021, 5) FRM-011, 6) TMP-022, 7) TMP-023, 8) TMP-024, 9) TMP-025, 10) TMP-026, and 11) TMP-027.
$299
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All Products
SYS-010: Risk Management Procedure
CourseThis procedure is compliant with EN ISO 14971:2019. Includes templates for documentation of design, risk management, and process risk management.
$299
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All Products
SYS-044: Software Development and Validation Procedure
CourseThis procedure is intended to meet the requirements of ISO 13485:2016, Clause 7.3.6 and 7.3.7 for design verification and design validation of medical device products, IEC 62304, ed. 1.1 and 21 CFR 820.30(a)(2)(i) and (g).
$399
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All Products
SYS-048: Usability Procedure
CourseThis procedure meets the requirements of IEC/ISO 62366-1 (2015) and the FDA guidance on Human Factors for Medical Devices. The bundle includes a template for a summative human factors study protocol, and a training webinar.
$299
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All Products
WI-007: Cybersecurity Work Instruction
CourseThis work instruction webinar bundle was updated to the 2025 FDA guidance and expanded to 25 pages. It provides detailed instructions and templates for compliance with the 2025 FDA Guidance on cybersecurity of device pre-market submissions.
$399