Monidor’s remote mon­i­tor­ing soft­ware receives an MDR cer­tifi­cate

An Oulu-based health tech­nol­o­gy com­pa­ny, Monidor, has been grant­ed an MDR cer­tifi­cate.
The cer­tifi­cate, obtained on August 15, 2024, is proof of the remote mon­i­tor­ing soft­ware’s com­pli­ance with the Euro­pean Union’s Med­ical Device Reg­u­la­tion (Class IIa), includ­ing the approval for the Monidrop W device. The cer­ti­fi­ca­tion process involved exten­sive doc­u­men­ta­tion, detailed descrip­tions of process­es and devices, and audits.

The MDR reg­u­la­tion has tight­ened the EU’s med­ical device and soft­ware require­ments, replac­ing the pre­vi­ous MDD direc­tive. It aims to har­mo­nize EU-lev­el reg­u­la­tions and enhance patient safe­ty.

The cer­tifi­cate was grant­ed by SGS FIMKO Oy (Noti­fied Body 0598).

About Monidor

Monidor offers a solu­tion for deliv­er­ing and remote mon­i­tor­ing intra­venous (IV) flu­id ther­a­py. The solu­tion con­sists of an accu­rate and com­pact device, Monidrop®, con­nect­ed to the infu­sion set and a remote mon­i­tor­ing appli­ca­tion. It has been designed for hos­pi­tal wards and home health­care. The inno­va­tion improves the over­all qual­i­ty of care and can result in short­er hos­pi­tal stays and few­er com­pli­ca­tions. It reduces the risks of mis­takes, improves work­flow, and saves work­ing time and mate­ri­als costs.

Source: Monidor