Designing and documentation | Jagiellońskie Centrum Innowacji

Designing and documentation

Jagiellońskie Centrum Innowacji Sp. z o.o. offers services within the scope of designing medical devices of class I and IIa, as per the implemented certified standards PN-EN ISO 13485:2016 and PN-EN ISO 9001:2015

 

We offer:

  • assessment of proposition (composition, administration route, indication for the device)
  • determination of the appropriate classification of the medical device
  • production and development of the medical device according to the valid regulations
  • development of technical documentation along with clinical evaluation
  • performing assessment of medical device clinical conformance
  • performing certification with or without the notified body
  • registration of the medical device

 

For a quote, please contact:

Telephone: +48 12 297 46 12

Mobile: +48 512 785 197
E-mail: agata.mleczkowska@jci.pl

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