BIOPIX-T (www.biopix-t.com ) is pleased to announce that its information security management system (ISMS) has been certified as per ISO/IEC 27001:2013 by DQS Hellas. Moreover, BIOPIX-T successfully audited for the extension of the scope of its ISO 13485:2016, also by DQS Hellas, to additionally include the “Technical Support” and also cover its new manufacturing premises.
Our new certification as per ISO/IEC 27001:2013 confirms that we have designed a system that can ensure the security and integrity of all the information that is handled by our company, be that of clients, suppliers or our own R&D and assets. In combination with our extended ISO 13485:2016 certification, it further enhances our ability to serve our mission to offer safe portable In-Vitro diagnostic medical devices (Instruments and kits) to every potential end-user, regardless of financial status, geographical location, and training. Doctors, healthcare providers and patients in both the developed and developing countries will benefit equally from our technologies, which intends to alleviate personal suffering and control disease outbreaks.
As always, this will be accomplished through employee and subcontractor’s involvement and ongoing education to ensure continuous improvement of our processes.
It is the policy of BIOPIX-T to develop, manufacture and market safe and effective products to applicable specifications that meet national and International Standards and Regulatory Requirements.
Dr. Papadakis, co-founder and CEO of the company stated: “ It has been an intense period implementing the ISMS and extending our QMS while preparing to enter the market. It was a strenuous process which required the involvement of the whole team of BIOPIX-T of which I am very proud of. As I have stated before, BIOPIX-T places the quality and regulatory conformity at the center of its development, understanding that the long-term existence and success of the company is dependent upon it, especially in view of the IVD Directive replacement by the much more demanding IVD Regulation next year. Again, the achievement of both certifications in such short time would have been impossible without the guidance and support from our regulatory and compliance consultants from PKNM Solutions Sarl.”
BIOPIX DNA TECHNOLOGY P.C. (https://biopix-t.com) was founded in December 2019 in order to commercialize a novel molecular diagnostic method, developed by the founding team, for the detection of nucleic acids at the point-of-care.
The company targets two healthcare-diagnostics related markets through the production of standardized assays for detection and monitoring of Infectious Diseases and Companion Diagnostics.