sound QMS to industrialise your healthcare product

There may be several options to industrialise the production of healthcare plastic parts, depending on the batch size. Our team will guide you through medical plastic injection-moulding and possible automation solutions, whether for disposables, implantable systems or small instruments.

Certified ISO 13485: 2016, we may validate the industrialisation through SAT / IQ / OQ / PQ procédures.

IMG_0291

Traceability and cleanliness

Together we will define:
> the cleanliness level, parts can be produced in a clean room environment
> the packaging
> the required documentation
> the part control

All the parts will be produced according to the ISO 13485 standards. Traceability is assured during the whole manufacturing process.

  • Clean roomsISO 7 & 8

Examples of realization

CG.TEC manufactures parts for medical applications: implantables parts, disposables, small instruments.

  • ISO 13485
  • Clean Rooms ISO 7 & 8
  • Traceability
  • Double packaging
  • Implantable PEEK
  • IQ / OQ / PQ validation
  • Micro-fluidics plates