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End-to-End Technical Document Support
- Collation and organization of data for technical documentation, GSPR, and clinical evaluation
- Authoring of technical documentation and GSPR in alignment with EU MDR and global regulations
- Toxicologist support with biocompatibility risk assessments
- Human-factor engineer support with usability studies
- Information reviews related to the design, function, performance, composition, use, claims, and clinical evaluations and ensure compliance with regulatory requirements
- Review of dossier structures per the regulations of different countries and regions
- Gap analysis to identify documentation deficiencies, including those related to:
- Device identification
- Description
- Intended use
- Artwork and Labeling
- Manufacturing information
- Risk management files
- Post-marketing surveillance
- Verification and validation of the device
- Review of clinical data and compilation of the Clinical Evaluation Report (CER)
- Development and assessment of risk management files, product specifications including labels, and Instructions for Use
- Compilation of documentation and specifications required for medical device manufacturing
