On November, 2017, Sense4Care started the process of certification of the Holter for Parkinson along with Tecno-Med and within the framework of PARK-IT2.0 project, an SME Instrument II project funded by the European Commission. It has taken 1 year and 7 months to overcome all the bureaucratic issues, pass the laboratory tests, achieve the manufacturing license by the Spanish Agency of Medicines and Medical Devices and pass the respective and rigorous audits performed by IMQ S.p.A. A long process, but finally the company has achieved the EC Certificate under the MDD 93/42/CEE and valid until May 2024.
The company which is in the final stage of the PARK-IT2.0 project is starting conversations with neurologists, health professionals, pharmaceutical companies and medical devices companies in order to introduce the device to the market.
Sense4Care is now producing 500 units as a first production of the product already certified. It will be available very soon. If you are interested, send a mail to firstname.lastname@example.org.