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:

Mobile: +48 515 075 500
E-mail: lukasz.kutrzeba@jci.pl