Medical Device and In-Vitro Diagnostics

Towards predictive and individualised medicine

What can we do to detect illness before the person actually becomes ill? That is medicine’s challenge for the future.

Areas of expertise

Area of expertise

  • Mechanical engineering
  • Electronic design
  • Embedded Software development & Automation
  • Validation & verification

References

  • Mechanical Development: one of our consultant has also been supporting the development of mammography instruments, writing technical specifications and using CREO for the design and ANSYS for simulations.
  • Software Development: another consultant has been supporting the software development of a blood screening device, from programming to writing the validation plan.

Area of expertise

  • Quality control
  • Quality assurance
  • Regulatory affairs

References

  • Quality assurance: a consultant is supporting the Quality assurance team for deviation management for pacemakers and defibrillators, conducting CAPA and Change Control requests.
  • Quality assurance: another consultant has supported the Quality team by structuring and updating the QMS, deviation management and updating the ISO 13485 v.16 certification.

Area of expertise

  • Supply Chain management
  • Purchasing
  • Lean Manufacturing
  • Logistic

References

  • Project management and serialisation: a consultant has been writing technical specifications for vision and marking systems, as well as liaising with suppliers and conducting equipment commissioning.

Area of expertise

  • Qualification & Validation (equipments & systems)
  • Cleaning validation
  • Lean Manufacturing

References

  • Process validation: a consultant has been supporting the ramp-up of the manufacturing lines for an insulin pump at an OEM in China. His responsibilities including equipment, In Process Control, documentation and process qualification.
  • Process validation: another consultant has been supporting the revamping of 3 sputtering equipment on different manufacturing lines.

Area of expertise

  • Project management R&D or engineering
  • Cost control / planning / risk management

References

  • Project management and serialisation: a consultant has been writing technical specifications for vision and marking systems, as well as liaising with suppliers and conducting equipment commissioning.

They trust us

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