Biohope receives ISO certification for the commercialization of IMBG test
Biohope’s quality system has got ISO 13485 certified by the international company BSI, allowing the European launch of IMBG test in 2020.
Biohope’s quality management system has now been certified under ISO 13485. This international standard ensures that Biohope meets quality requirements for the design, development, manufacture and marketing of medical devices and services.
For the adaptation of our procedures to the ISO 13485 standards, we relied on the support of the international company BSI, until the successful certification of Biohope’s and IMBG processes. BSI have helped clients comply with regulations for more than 100 years, with 87 offices in 31 countries across the world.
This certification will allow Biohope to offer the IMMUNOBIOGRAM® (IMBG) test at the highest standards of quality, according to the European legislation on medical devices.
IMBG is a unique In Vitro Diagnostic (IVD) immunoassay that evaluate patient´s sensitivity/resistance profile to a panel of the most used immunosuppressive drugs in clinical practice. The test allows physicians to predict and monitor the response of patients‘ immune system cells and to use this information for the design of the most adequate treatment for each patient.
The IMBG test performance and reproducibility was already validated in patients undergone renal transplant in the TRANSBIO clinical study and we expect to launch IMBG test to the European market in Q1 2020.
