free css templates

Medical Devices

Ensuring cost-effective, timely, high-quality and medical-device compliant development processes

Particles of Services for Medical Device Vendors

  • Regulations and Standards
    Implementation of regulations and standards with the goal of certification/registration of a medical device (ISO 13485, 21 CFR 820, Medical Device Directive 93/42/EEC, Medical Device Regulation EU 217/745, IEC 60601 series, IEC 62304, IEC 62366, ISO 14971, ...)
  • Development Processes
    Definition of medical device compliant development processes
  • Quality Processes
    Establishment and implementation of risk management, usability, and quality management processes
  • Requirements Management
    Medical device compliant creation and tracking of system requirements
  • Verification & Validation
    Creation and implementation of verification and validation processes and tests
  • Documentation
    Medical device compliant creation of technical documentation
  • Authorities
    Dialog with authorities and notified bodies (national and international)
  • Project Management
    Project management for medical device development and manufacturing