Medical Device Manufacturer

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

QACA is 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 13485:2016)
  • Production quality assurance (based in ISO 13485:2016)
  • Full quality assurance (ISO 13485:2016)