PC: Canva
Ensure your software meets the stringent requirements of FDA, EU MDR, and ISO 13485 standards. At Elexes, our certified software documentation specialists create, review, and validate documents critical to regulatory success.
Whether you're preparing for a 510(k), CE Marking, or MDSAP audit, our team of regulatory software documentation experts ensures your documents are accurate, audit-ready, and fully aligned with international regulatory frameworks.
PC: Canva
Software is the backbone of modern medical devices. In the realm of SaMD or embedded systems, incomplete or non-compliant documentation can be the greatest single cause of regulatory delays.
At Elexes, our documentation services cover:
⦿ Traceability originating from Requirements to Testing
⦿ Documents aligned with FDA, EU MDR, IVDR, and ISO 13485
⦿ Supporting risk management (ISO 14971)
⦿ Audit-ready templates
Since the past, the complex technical content has been translated into concise and acceptable documentation, accepted by startups and Fortune 500s.
⦿ Software Development Plan (SDP)
⦿ Software Requirements Specification (SRS)
⦿ Software Design Description (SDD)
⦿ Software Architecture Chart
⦿ Risk Management Files (RMF)
⦿ Software Verification & Validation (V&V) Protocols and Reports
⦿ Software Traceability Matrices
⦿ Cybersecurity Documentation
⦿ User Manual and Installation Instructions
⦿ Bug Reports and Revision Histories
Our team makes sure that every file is in line with regulatory guidelines such as FDA Guidance for Software as a Medical Device (SaMD), IEC 62304 Compliance (Software Lifecycle), and ISO/TR 80002-1
Learn more about our Medical Device Software Development Services
Our documentation is structured to meet international standards including FDA’s 21 CFR Part 820, EU MDR Annex II, and ISO 13485:2016.
We customize documentation based on your software’s classification, risk level, and intended use, whether it’s standalone SaMD or embedded firmware.
We coordinate closely with your engineers to gather accurate inputs and ensure real-time updates in design, testing, and release cycles.
From test protocols to deviation reports, we provide end-to-end support in meeting validation expectations.
We don’t just help you meet the immediate goal. Our documentation is designed to stand up to future audits, change control, and ongoing quality system reviews.
Designed for Compliance, Optimized for Speed
Our experienced software documentation specialists are ready to help you meet global compliance with confidence.
A software documentation specialist prepares, reviews, and maintains technical and regulatory documents essential for medical device software compliance.
Proper documentation is essential for regulatory submissions like FDA 510(k), CE Marking, and ISO audits. It ensures software safety, traceability, and quality.
Key regulations include FDA’s guidance on SaMD, IEC 62304, ISO 13485:2016, ISO/TR 80002-1, and EU MDR Annex II.
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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