Scandinavian ChemoTech attains ISO 13485 certificate
During 2021 ChemoTech has, after securing its CE-mark for its IQwave system, continued to develop its quality management system to ensure that it follows both existing and upcoming requirements for medical devices.
Scandinavian ChemoTech has attained certificate for ISO 13485 issued by RISE, Research Institute of Sweden AB. The company’s quality management system for medical devices fulfils the requirements of SS-EN ISO 13485:2016 with respect to “Design and development, production, marketing, sales, distribution and services of products within electroporation”.
“This is a profound quality accomplishment for the company’s organization which is essential for regulatory procedures in countries outside of Europe, outside of EEC and MDR (Medical Device Regulation). The company’s quality work continues but now from an improved level for maintenance of the ISO certificate. Annual audits will be performed by RISE. The certificate is valid until 2025-01-26.” - says Eva Ståhl Wernersson QM/RA Director at ChemoTech
“This is yet another milestone for ChemoTech and improves our ability to market and finalise the registration of IQwave™ in some of our approached markets.” - says Mohan Frick CEO and Co-Founder of ChemoTech
This disclosure contains information that ChemoTech is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 01-02-2022 12:30 CET.
For more information, please contact:
Mohan Frick, CEO
Phone: +46 (0)10-218 93 00
Certified Adviser: Erik Penser Bank, Tel: +46 8 463 80 00, E-mail: certifiedadviser@penser.se
Scandinavian ChemoTech AB (publ)
ChemoTech is a Swedish medical technology company based in Lund that has developed a patented technology platform to offer cancer patients access to a new treatment alternative, Tumour Specific Electroporation™ (TSE), available for treatment of both humans and animals. There are a large number of cancer patients whose tumours for various reasons cannot be treated by conventional methods but where TSE can be a solution. Therefore, the company continuously evaluates new opportunities and areas of application for the technology. ChemoTech's shares (CMOTEC B) are listed on Nasdaq First North Growth Market in Stockholm and Erik Penser Bank is the company's Certified Adviser. Read more at: www.chemotech.se.
