Monidor Oy

Monidor Oy receives ISO 13485 certification

Monidor Oy is pleased to announce that it has been certified to ISO 13485:2003 and EN ISO 13485:2012 by Notified Body – SGS Fimko Ltd for design, subcontracted manufacturing, and sales of infusion monitors for the IV administration sets.

ISO 13485 sets very high-level requirements for the Quality Management Systems (QMS), and it is a mandatory enabler to design, manufacture, and sell medical devices. It also requires that the company in question continuously meets the customer needs and the applicable regulatory requirements. Now the achieved certification is one important step on Monidor’s path to become the leading infusion monitoring device manufacturer.