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Download Our Comprehensive SaMD Compliance Checklist for Medical Writing
Developing Software as a Medical Device (SaMD) requires rigorous documentation to meet Regulatory, safety, and quality standards globally. Whether you are at the initial classification stage or finalizing your post-market surveillance reports, our detailed checklist ensures you never miss a critical document in your medical writing process.
Fill the form below to download the Checklist
What’s Inside This Checklist?
Our SaMD Compliance Checklist is a practical, ready-to-use guide designed to help medical writers, Regulatory professionals, and software developers:
- Identify required documentation based on your SaMD classification
- Cover all essential development and verification documents, including Software Requirements Specification, Software Architecture Design, and Verification & Validation reports
- Align with key Regulatory frameworks such as FDA, EU MDR, and ISO 13485
- Manage risk and usability validation efficiently
- Prepare comprehensive clinical evaluation and post-market surveillance documentation
- Maintain traceability with matrices linking requirements, design, and tests
- Address cybersecurity risk assessment where applicable
This checklist is tailored to adapt to your product’s risk class and Regulatory environment, making it an indispensable tool for compliance and quality assurance in SaMD medical writing.
Who Should Use This Checklist?
- Medical writers specializing in SaMD
- Regulatory affairs professionals preparing submission dossiers
- Software developers and quality engineers working in medical device development
- Clinical evaluators managing post-market clinical follow-up (PMCF) activities