Prolight Diagnostics achieves ISO 13485 accreditation

Prolight Diagnostics, developer of the digital point-of-care platform Psyros™, today announces that their subsidiary Psyros Diagnostics has gained accreditation to the industry standard ISO 13485, which sets out the requirements for a quality management system (QMS) specific to the medical devices industry.

“The accreditation shows that our quality processes meet global quality requirements which is a prerequisite for market approval in the US and Europe. We see the accreditation as proof of the high standard in our med tech development when we develop a safe, high-quality point-of-care platform providing very accurate and fast diagnostic results,” said Ulf Bladin, CEO of Prolight.