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Medical Device Manufacturer

CE marking is a legal requirement for medical devices intended for sale in Europe.

QACA having cooperation with TSU Piestany, Slovakia to perform product certification under the MDD.

These services include:

  •  Technical documentation/file or design dossier assessment/review
  •  Device type examination
  •  Product quality assurance (based in ISO 13485)
  •  Production quality assurance (based in ISO 13485)
  •  Full quality assurance (ISO 13485)