Certification of a Medical Device (Medication Application)

 

Balda is a specialist in plastic solutions where precision, quality, safety and customized specifications are important. The group works for customers in the healthcare industry in the fields of diagnostics, pharmaceuticals and medical technology, as well as in the eyewear, electronics and automotive sectors.

WQS was entrusted with the certification of a sub-area of Balda, in which a drug application system is specifically produced and distributed. The Medical Device in question, “dial-the-dose” is highly innovative and allows the appropriate dose to be set (from 0.5 to 6 ml) before dosing a liquid drug (such as fever syrup). The division is made in 0.5 ml steps with a precision of less than 5%. In terms of classification, this function makes it a Class I product with a measuring function. The involvement of a notified body is obligatory for this. We have decided on DQS-Med, based in Frankfurt, as the certification body.

We would like to take this opportunity to thank all the partners for their quick, friendly and smooth cooperation.