Pharmacolog i Uppsala AB has carried out a certification of its quality system in accordance with ISO 13485: 2016. Review and certification were conducted by Svensk Certifiering Norden AB.
Pharmacolog AB has today received its certificate in accordance with ISO 13485: 2016 (Medical devices – Quality management system – Requirements for regulatory purposes). The certificate is issued by Svensk Certifiering Norden AB and certifies that Pharmacolog AB has a quality management system that meets the requirements regarding development, manufacture, distribution, installation and service of medical technology products. ISO 13485 is an internationally recognized standard that complies with the regulations and regulatory requirements required to provide medical devices and related services in Europe. The standard is well established and internationally accepted.
Mats Högberg, CEO, comments: “The certification of our quality system and the CE marking of our product DrugLog is an important step in ensuring that we have a functioning quality process in the further development of a new generation of medical technology products. Having the regulatory requirements in place and having a quality system that works, which the certificate is proof of, is a prerequisite for us to be able to act in the market. Especially important as we have entered into exciting partnerships and are about to establish new products.”
Pharmacolog is specialized in developing systems and solutions for more effective and safer use of intravenous drugs. The company’s first product, DrugLog®, enables a nurse or pharmacist to quickly and easily verify that an injectable drug has the right identity and concentration. Pharmacolog’s long-term vision is an individually optimized medication for each individual patient, considering all available parameters in the control and distribution of the drug. Further information regarding the company is available at http://www.pharmacolog.com. The company’s Certified Adviser is Mangold Fondkommission AB, which can be reached on telephone number +46 8-5030 15 50 or through CA@mangold.se.