BiomAdvanced Diagnostics is ISO 13485 certified by BSI under certificate number MD 775018.

In our annual recap, we alluded to it, and now we’re thrilled to share it with you – we successfully completed the audit for ISO 13485 certification of our quality system and we are officially certified.

Why does this matter ?

Companies involved in the development and manufacturing of Medical Devices are REQUIRED to have a Certified Quality System in accordance with the ISO 13485 standard.

The audit, conducted over 1.5 days in December 2023, resulted in the identification of only two minor non-conformities (which, according to the two auditors themselves, is quite remarkable), both of which were promptly addressed in January.