Capabilities
- Develop clinical investigational protocols, informed consent, and case report forms; perform clinical research management (IRB approval, setup, site education, maintenance, monitoring, data integrity, recordkeeping, annual reviews, closure).
- Identify device characterization test protocols and usage recommendations (verification and validation testing, biocompatibility, disinfection/sterilization, etc.).
- Preparation and successful clearance of FDA 510(k) submissions.
- Develop corporate SOPs for FDA QSR compliance.
- Ombudsman for ITS/UL testing to voluntary and internationally-recognized standards.
- Prepare analysis white papers detailing aspects of FDA regulation.
- Technical and electronic publications - develop, prepare, review, edit Operator's and Technical manuals. First-ever electronic device submission to FDA.
- Database development.
