BIOPIX-T certified as per ISO 13485:2016

BIOPIX-T (www.biopix-t.com ) is pleased to announce that its quality management system (QMS) has been successfully certified as per ISO 13485:2016 requirements by DQS Hellas, with scope “Design and Development, Production, Storage and Distribution of nucleic acid amplification kits (COV19 qc LAMP kit and Flu A qc LAMP kit) and instruments (Pebble qc LAMP platform)”.

Our ISO 13485:2016 certification serves 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.

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: “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 with the eminent IVDR requirements, it was imperative that we implemented an adequate QMS from the start. Conforming with the ISO 13485 is the basis for not only achieving eventually the CE marking for our products but also passporting ourselves to the global markets. The process of receiving this certification was a strenuous one and required a collective effort and commitment from the whole BIOPIX-T team but would have been impossible to achieve in such short time without the valuable training and guidance by our regulatory and compliance consultants from PKNM Solutions Sarl.”

About:  

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.  

BIOPIX-T operates out of the Science and Technology Park of Crete (STEP-C).

BIOPIX-T CERTIFICATE Download