Medical Device Documentation
At ScientificWrite, we specialize in creating precise, compliant, and comprehensive documentation to support the development, regulatory approval, and marketing of medical devices.
We understand that thorough, well-organized documentation is crucial not only for regulatory compliance but also for the safe and effective use of your medical devices.
Our writing team combines scientific expertise with deep knowledge of medical device regulations (FDA, MDR, ISO 13485), ensuring that every document we prepare meets the highest standards of clarity, accuracy, and compliance.
Our Medical Device Documentation Services Include:
Preparation of complete documentation sets required for CE marking and international approvals.
Comprehensive evaluation reports in line with the latest EU MDR requirements and MEDDEV 2.7/1 Rev 4 guidance.
- Technical Files and Design Dossiers
- Clinical Evaluation Reports (CERs)
- Risk Management Documentation
- Instructions for Use (IFU) and User Manuals
- Regulatory Submission Support
- Post-Market Surveillance (PMS) Reports
