Quality Assurance
  • Designing and establishing quality systems, development, ISO 13485 certification, maintenance
  • Optimizing the Design Control and Risk Management processes
  • Design Control procedures and implementation
  • Hands on execution of Design Verification & Validation on site
  • Design Control audits
  • DMR (device master record)
  • Process validation (IQ/OQ/PQ)
  • Change Control
  • Development & Oversight of Usability & Human Factors program
  • Oversight of Product Reliability program
  • Risk Management program development and implementation per ISO14971:2007
  • CAPA (Corrective & Preventive Action)
  • Software QA

Turnkey Quality Assurance Services Include:

  • ISO & CE certification
  • Planning and running design Verification & Validation (partnering with selected test houses)
  • Quality Management system maintenance (QA on premise)