CEO Jane Theaker comments: “Gaining ISO 13485 accreditation has required a huge team effort and I am so proud of what has been achieved.
“The accreditation shows we have the necessary quality system in place to ensure our Actiphage TB Blood test is being developed and manufactured to the high standards expected from a diagnostic manufacturer and this will assure the confidence of our partners and collaborators.”
ISO 13485 is designed to be used by organisations involved in the design, production, installation and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes.
PBD Biotech has gained approval number ISO13485 – 00044246 for “control of development, control of manufacture, and distribution of in vitro diagnostic kits for infectious diseases”.