PC: Canva
Developing medical device software is only half the battle, documenting it accurately is what drives regulatory approval. At Elexes, our software documentation service is tailored for FDA, EU MDR, and other global standards. Whether you're working on embedded systems, SaMD, or complex software integrations, our team helps prepare audit-ready documentation that speaks the regulator’s language.
We cover the full suite of required documentation from software requirements and risk analysis to validation protocols and traceability matrices, ensuring that your submission is compliant, clear, and on time.
PC: Canva
With evolving standards like FDA QMSR, IEC 62304, and ISO 13485, software documentation must go beyond simple notes and meet global expectations.
Our experts work closely with your development and quality teams to create documentation that is not only regulation-ready but also scalable and easy to maintain. We offer:
⦿ Custom documentation aligned with your design and QMS processes
⦿ Cross-functional collaboration for seamless integration
⦿ Audit-defense ready files for Notified Bodies, FDA, TGA, Health Canada & more
Looking for support beyond documentation? Our Software Validation Services and IVD Consulting pages offer integrated solutions.
We provide a full range of medical device software documentation support services including:
⦿ Software Development Plan (SDP)
⦿ Software Requirements Specification (SRS)
⦿ Software Architecture and Design Documentation
⦿ Software Unit and Integration Test Reports
⦿ Software Verification & Validation Protocols and Reports
⦿ Traceability Matrix (SRS to Code, Test, Risk)
⦿ Software Risk Management per ISO 14971
⦿ Cybersecurity Documentation
⦿ SOUP (Software of Unknown Provenance) analysis
⦿ Change Control Documentation
⦿ Post-market Surveillance Plans (PMSP) & Reports (PMSR)
We align documentation with regional regulations like FDA 21 CFR 820, EU MDR, Health Canada, and TGA to support seamless market entry.
All documentation we create meets the expectations of IEC 62304, including appropriate classification and lifecycle support activities.
Whether you’re building from scratch or retrofitting existing files, our documentation adapts to your workflow, not the other way around.
We liaise with your R&D, QA, and Regulatory teams to ensure the documentation is technically correct and compliant.
With clear formatting, traceability, and validation structure, our files reduce audit risks and review timelines.
Software documentation can be simplified when done strategically. Explore how our documentation services streamline compliance.
Need FDA-ready documentation for your medical software? Get compliant with Elexes’ expert software documentation services
It includes structured records of software requirements, design, verification, validation, risk management, and traceability for regulatory compliance.
Yes, IEC 62304 is the key international standard for medical device software lifecycle documentation.
Elexes provides customized software documentation aligned with FDA, MDR, and IEC 62304 requirements. We create audit-ready files and traceability matrices.
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.
We offer different services that will help you not only keep your product well in boundaries of regulations but also speed up the entire approval process. Some of these services are -
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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