Whether your software is embedded in a medical device or part of a standalone SaMD solution, software validation documentation is a regulatory requirement, not a choice. At Elexes, we help ensure that your software validation meets the strict requirements of FDA 21 CFR Part 820, IEC 62304, and ISO 13485. From risk classification to traceability matrix, we prepare the documentation regulators expect.
Let us help you eliminate gaps in your documentation and avoid costly delays in approvals
Regulators across the globe require documented proof that your software works as intended, safely and effectively. Elexes provides end-to-end support for generating software validation documentation tailored to regulatory standards.
Our team aligns your documentation with software lifecycle requirements including:
⦿ Software requirements specifications (SRS)
⦿ Design documentation and traceability
⦿ Software design verification and validation protocols
⦿ Test reports and defect tracking
⦿ Risk management aligned to ISO 14971
We’ve supported clients in the U.S., Europe, Canada, and Australia with IEC 62304-compliant validation files, helping them avoid surprise inspections and rejections.
This side-by-side comparison shows how U.S. and international standards align and where they differ to help you stay compliant across markets.
Poor or incomplete documentation can lead to product recalls, warning letters, or market withdrawal. Our medical device software validation documentation services are focused on audit readiness, making sure every requirement is traceable, tested, and backed by evidence.
We cover documentation for:
⦿ Embedded software in medical devices
⦿ Software as a Medical Device (SaMD)
⦿ Lab automation and diagnostic software
All files are aligned with Design History File (DHF) and Device Master Record (DMR) expectations.
Don’t miss out! Download our Free Software Validation Documentation Checklist to avoid common FDA pitfalls.
We’ve broken down the complex validation process into clear, visual pathways. See where you stand and what comes next.
Software validation documentation provides objective evidence that a software system performs as intended and complies with regulatory requirements such as FDA 21 CFR Part 820 and IEC 62304.
Yes. The FDA mandates software validation documentation for any device containing software, including SaMD documentation and embedded systems, as part of 510(k), PMA, or De Novo submissions.
Absolutely. Elexes has extensive experience creating IEC 62304-compliant software validation documentation, tailored for global market approvals including CE Marking, TGA, and Health Canada.
Elexes offers a globally recognized ISO 13485 certification consultant who is renowned to enhancing your business credibility in the medical devices industry.
Our presence across the globe ensures audits are conducted by local-language auditors, facilitating clear communication and understanding.
Our experts provide guidance and consultants to help you adhere to necessary regulations, ensuring your products meet all legal requirements and is compliant to all necessary standards.
At Elexes, we offer to assist in securing additional local certifications, enabling you to manufacture and sell medical devices in various markets across the globe.
We offer complete confidentiality to all our clients which makes us one of the most trusted regulatory and quality compliance consulting.
CEO Masterlink, Arizona
CEO Novasignal, Los Angeles
President ViDava, Florida
Sr. Exe Treedental, Hong Kong
Manager Outset Medical, California
CTO Jana Care, Massachusetts
MD Blackrock Pharma, England
VP Regulatory AliveCor, California
Owner Liz Inc., Arizona
CEO Radformation, New York
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