Human studies

All clinical studies are conducted according to the guidelines established in the Declaration of Helsinki. Clinical investigation plans with patient information and consent forms are submitted to an appropriately constituted Ethical Committee by the Investigator prior to the commencement of the study. Ethical Committee approval is required prior to initiating the investigation.

GTIMD and Investigator submit the appropriate documentation necessary for Ethical Committee approval. In particular the clinical investigation plan, the informed consent, and any other written information provided to patients, and/or study procedures directly affecting the patient.

All information provided to patients including any advertisements for the clinical investigation within the clinical trial center or in the public press needs approval of both GTIMD and Ethical Committee prior to being presented to the patients under any format.

Project Management
  • Risk Assessment
  • Engineering Services
  • Product Design
  • Quality Compliance
Conceptual Design Services
  • Benchmarking
  • Brainstorming
  • Prototyping
  • Bench Testing
Device Development
  • Concept Generation
  • Detailed Design
  • Feasibility Development
  • Design Verification
  • Design Validation
  • Transfer to Production
Device Commercialization
  • Design for Manufacturability
  • Process Validation
  • Technology Transfer
Device Manufacturing
  • Components
  • Subassemblies
  • Finished Devices