Technical Documentation for Medical Device Software (SaMD)
Our Services Include:
- Software Requirements Specifications (SRS): Clearly defined and structured documentation of software functionalities
- Risk Management Documentation: Comprehensive analysis and mitigation plans in line with ISO 14971
- Verification & Validation Reports: Detailed reports to ensure your software meets regulatory expectations
- User Manuals and Design Documentation: End-user documentation and design overviews for seamless approval
Why Choose Us?
Expertise in medical device regulations (ISO 13485, IEC 62304, MDR, FDA 820.30)
High-quality, audit-ready documentation for global markets
Tailored support for startups and established medical device companies
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