In line with our strategy of becoming a full-fledged In Vitro Diagnostics (IVD) company 2cureX is happy to announce that we have been certified for ISO 13485:2016 compliance. Certification was issued by Bureau Veritas Certification Denmark A/S, a certification company accredited by DANAK.
ISO 13485:2016 is the latest version of the standard for design, production, installation and servicing of Medical Devices and related services. For a Medical Device (including an In Vitro Diagnostic device) to be CE-marked, the manufacturer must prove that its Quality Management System fulfils a series of requirements. ISO 13485:2016 ensures compliance with those requirements and has therefore become the standard choice for all relevant players in the industry.
“This is a very important step for us”, said Ole Thastrup, CSO of 2cureX. “Being certified for ISO 13485:2016 shows the high degree of maturity we have achieved when it comes to our product design, development and manufacturing activities. It is also an important milestone in our path towards having products and services that are compliant with the upcoming EU Regulation 2017/746, known as IVD-R”.
“We are very proud of this achievement”, stated Fernando Andreu, CEO of the company. “This has been an all-company effort that required true cross-functional teamwork and it sets us apart from other companies and institutions in the field of Functional Precision Oncology. In our effort to make patient-derived 3D microtumors part of routine clinical practice, quality and regulatory compliance is the only way to go. Furthermore, most hospitals require their suppliers to have a certified QMS, so we see this certification as a must in our commercialization efforts”.
2cureX has two sites involved in product design and development activities, one located in Copenhagen, Denmark and one in Hamburg, Germany. The ISO 13485:2016 certification the company has achieved covers both sites.
For more information about 2cureX:
Fernando Andreu, Chief Executive Officer
Telephone: +45 2279 5399
2cureX has developed the IndiTreat® (Individual Treatment) test. IndiTreat® establishes thousands of 3D microtumors that functionally resemble the patient's tumor and identifies the approved cancer treatment that most effectively kills the patient's tumor. Immediately after the test, the patient is given the selected treatment.
The first IndiTreat® product in metastatic colorectal cancer is introduced to the European market. Subsequent products help patients at different stages of colorectal cancer and other solid cancers.
The company is listed on Nasdaq First North Growth Market in Stockholm (symbol: "2CUREX"). For more information about 2cureX visit www.2cureX.com.
Certified Adviser: Redeye AB, +46 8 121 576 90, firstname.lastname@example.org.
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2021 07 19 - ISO 13485 certification