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