Technical Documentation
Accurate and comprehensive technical documentation is fundamental to regulatory approval. Our experts carefully prepare and maintain technical files, including all required documents such as design specifications, verification and validation plans and reports, to support regulatory submissions and demonstrate product compliance.
- Design and development: We provide full design control support during medical device development to ensure efficient product design development. We guide clients through all design control elements mandated by FDA 21 CFR 820.30 and ISO 13485, including design inputs, design outputs, design verification and validation, design transfer, design history files/medical device files and design reviews.
- Risk Management: Effective risk management is essential for identifying, evaluating, and mitigating potential hazards associated with medical devices. Our experienced team assists you in developing robust risk management processes and documentation, including hazard analysis, risk assessment, and risk control measures, to ensure product safety throughout its lifecycle.
- Clinical Evaluation: Clinical evidence is paramount in demonstrating the safety and performance of medical devices. We offer comprehensive clinical evaluation services, from literature reviews and data research and analysis to report preparation, to support regulatory submissions and compliance with clinical requirements.
- Biological Evaluation: Ensuring the biocompatibility of medical devices is crucial for patient safety. We conduct thorough biological evaluations, following ISO 10993 and other relevant standards, to assess potential risks associated with device-material interactions and ensure compliance with regulatory requirements.
- Usability Engineering: User-centered design is essential for creating medical devices that are safe, effective, and easy to use. We conduct usability assessments, including user research, task analysis, and usability testing, to optimize device usability and enhance user satisfaction.