Monidor Oy has been awarded the ISO 13485:2016 certificate in October 2018
Monidor Oy is pleased to announce that it has been certified to ISO 13485:2016 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 achieved certification update proves Monidor’s continuous ability to meet highly demanding quality requirements, that are essential for medical devices.