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Prolight Diagnostics achieves ISO 13485 accreditation
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Beskrivning
| Land | Sverige |
|---|---|
| Lista | Nordic SME Sweden |
| Sektor | Hälsovård |
| Industri | Medicinteknik |
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.
For further information, please contact:
Prolight Diagnostics AB (publ)
E-mail: info@prolightdx.com
Telephone: +46 73 582 39 87
Website: www.prolightdx.com/en/
About Us
Prolight Diagnostics AB develops innovative Point-of-Care (POC) systems. These are small, portable instruments and disposable cartridges for performing in-vitro diagnostic (IVD) tests from a drop of blood.
We want to offer the foremost POC systems on the market for quick, reliable diagnosis of acute events. Our launch product will be for the measurement of troponin, to aid in the rule-in and rule-out of myocardial infarction.
The company’s share is traded on the NGM Nordic SME marketplace, under the ticker PRLD.