Omsbar Medical Device Design Manufacturing and Regulatory Services



Medical Device Design Clinical Evaluation Export Certification Project Management Product Registration Quality Management Regulatory Affairs Verification and Validation OMSBAR Contact Information Training Design Manufacturing Omsbar Medical Device Consultancy


Project Management
Omsbar is experienced in managing design project types including:
  Sterile
  Non-sterile
  Electrically powered, patient contacting
  Software controlled
  Surgically invasive
  Implantable
  Remote telemetering

Management of individual project phases can be provided, including:
  Component or sub-system design
  Identification of system requirements
  Software specification and construction
  Project management
  Procedures and Work Instructions writing
  Documentation
  Integration with QA and RA systems
  Links to product registrations
  Hazard Analysis and Risk mitigation
  Clinical evaluation
  Verification and Validation - electrical hardware, software and disposables


We provide full liaison with sub-contractors and regulatory authorities. Hazard analysis and subsequent risk assessment is an integral part of such processes and Omsbar is experienced in incorporating these into design projects, ensuring maximum project effectiveness.