Demonstrated globally-recognized standards in safety and quality management as a medical software manufacturer.
SEOUL, SOUTH KOREA (PRWEB) AUGUST 16, 2022 - Deep Bio, a pioneer in medical AI for pathologic cancer diagnostics, announced that it has been recently granted Medical Device Single Audit Program (MDSAP) certificate.
MDSAP is a unified global regulatory audit of medical device manufacturing operated by the International Medical Device Regulators Forum (IMDRF). MDSAP-certified manufacturers are considered to have satisfied the relevant requirements of the regulatory authorities participating in the program including the United States (FDA), Canada (Health Canada), Japan (MHLW), Australia (TGA), and Brazil (ANVISA).
Through the MDSAP certificate, Deep Bio demonstrated its commitment to high product quality standards and safety management. Also, it is expected that Deep Bio will be able to enter the US, Canada, Japan, Australia, and Brazil markets faster and more efficiently in the future, saving time and cost associated with Quality Management System (QMS) in each market.
“Obtaining MDSAP certification is meaningful in that our products are recognized for outstanding quality management on top of innovative technology in the global market,” said Sun Woo Kim, CEO of Deep Bio. “In particular, as these five countries account for more than half of the global medical device market, I am confident that passing the MDSAP audit can be a great opportunity to expand our presence in overseas markets. At the same time, we will make every effort to strengthen our differentiated technology through continuous product research and establish ourselves as a leader in AI-based cancer diagnostics in global markets,” added he.
Deep Bio continues to focus on not only AI diagnostics but also R&D and presenting the results in various international conferences and events. The company also continues to build its presence in the global market through overseas digital pathology solution providers in the US, Europe, and India, as well as conducting research cooperation with Stanford Medical School, Harvard Dana-Farber Cancer Center, and other top research institutions in the US.
About Deep Bio
Deep Bio Inc. is an AI healthcare company with in-house expertise in deep learning and cancer pathology. As the country’s first to obtain Korea’s MFDS (Ministry of Food and Drug Safety) approval of an AI-based cancer diagnostic support solution, Deep Bio's vision is to radically improve efficiency and accuracy of pathologic cancer diagnosis and prognosis, by equipping pathologists with deep learning-based IVD SaMDs (In Vitro Diagnostics Software as a Medical Device), for optimal cancer treatment decisions. Deep Bio is also actively engaged in the research space and maintains ongoing collaborations with top US medical centers. To learn more, visit http://www.deepbio.co.kr. DeepDx® Prostate is a clinically-validated AI for prostate core needle biopsy tissue image analysis. Whole-slide images (WSIs) of H&E-stained biopsy tissue specimens are analyzed for prostate cancer, Gleason scores, and grade groups. Extensively tested at US CLIA labs (700k cores between 2019 and 2021), DeepDx® Prostate can alleviate the shortage of pathologists and the resultant increase in workload, while reducing diagnostic subjectivity and variability.” To learn more, visit http://www.deepbio.co.kr.