Technical Documentation for Medical Device Software (SaMD/MDSW)
Delivering Compliant Medical Device Software with Complete Technical Documentation
Developing medical device software is not just about writing code; it’s about building a product that is ready for regulatory submission under both EU MDR 2017/745 and FDA 21 CFR 820.30.
At QMLogic, we ensure that software development and technical documentation evolve together as one seamless process.
We understand that technical documentation is not an afterthought; it’s an integral part of the medical device software lifecycle.Every requirement, every risk, every verification step is linked and traceable, ensuring your submission package is complete, consistent, and compliant.
“We don’t just develop your software, we develop your submission-ready product.”
Our Approach in Technical Documentation
Our experience shows that disconnects between software design and documentation cause:
- Contradictions between intended use, risk management, and clinical evaluation
- Gaps in cybersecurity documentation or unresolved risk controls
- Delays in regulatory submission
- Costly reworks and loss of market time
To prevent this, our design control framework integrates documentation directly into the development process, from the first user need to the final verification and validation report.
TechDoc Aligned from Concept to Submission
By choosing QMLogic, you get a partner who ensures that all parts of your Design History File (DHF) or Technical Documentation (TD) remain synchronized:
- Product description and intended purpose/intended use are aligned with product requirements
- Medical device classification does not contradict the risk management file
- Risk management is connected with the cybersecurity process
- Verification and validation activities consistent with requirements and design outputs
- Post-market activities, including risk and vulnerability tracking, are planned and executed in a timely manner
This ensures every document reflects the same truth: your product’s actual design, safety, performance, and effectiveness.
TechDoc Integrated Expertise
In QMLogic, we have designed and implemented technical documentation structures and design control processes for numerous medical device companies.
We combine expertise in:
- IEC 62304 medical device software lifecycle
- FDA 21 CFR 820.30 design control documentation
- ISO 14971 risk management
- IEC 81001-5-1 cybersecurity
This integration of engineering and regulatory expertise ensures that your documentation tells the same story as your software, a story of compliance, safety, and readiness for approval.