Biomedical iso certification

End markets include human and animal nutrition and health, personal care, pharmaceuticals, automotive, coatings and paint, electrics and electronics, life protection and housing.

The company is headquartered in the Netherlands, with locations on five continents. DSM is listed on Euronext Amsterdam. More information: www. This press release contains forward-looking statements. Strong quality management requires some extra time and money. But cutting corners in manufacturing doesn't always increase ROI for the buyer.

That's because lower quality parts are more likely to downgrade performance and increase safety risk. This is a step in the right direction, but ISO is a general standard applicable to any industry.

It primarily focuses on procedures that ensure customer satisfaction. However, biomedical equipment serves a very different purpose than other devices. Sure, customer satisfaction is important. But quality and risk mitigation can literally make a difference between life and death for clinical equipment used in patient care every day.

But the additional rigorous risk management strategies of ISO give medical device manufacturers even more control over product quality. That level of control keeps patients safe, hospitals in compliance, and helps providers deliver effective, value-based medical care. The most important part of the QMS is documentation.

Beginning with design planning, manufacturers must record every process and quality checkpoint. The first target application for its technology is to test for the presence of bacterial contaminants in the blood supply. Bacterial contaminants in platelets and red blood cells represent the greatest lethal infectious risks in transfusion medicine today, and no rapid, simple methods are presently available to effectively address this threat.

Each year an estimated 17 million patients receive more than 60 million units of these individual blood components in North America, Europe and Asia. The Company's first product is the Platelet PGD Test — a rapid test for the detection of bacterial contamination in platelets. Just added to your cart. Continue shopping. Facebook Twitter Pinterest Instagram. Hours of Operation: Mon. Our R2 Certification Yes!