(Moncton, NB) October 22, 2021 – Picomole, has received ISO 13485 certification, positioning our company for the launch of our ground-breaking breath sampling technology in the US and Canada.
“Receiving ISO 13485 certification is an important milestone for Picomole. This achievement further confirms our company’s commitment to the quality, safety and reliability of our devices. We have worked hard to attain our ISO 13485 certification and are thrilled for the exciting things to come for our company and the users of this technology.” said Picomole CEO Stephen Graham.
Our breath sampling device – SohnoXB – is listed with the United States Food and Drug Administration (FDA) and Picomole has received a Medical Device Establishment Licence (MDEL) from Health Canada. Global regulatory agencies recognize ISO 13485 certification as the gold standard for companies developing and commercializing medical devices, as it demonstrates best practices for quality management. This certification demonstrates, by third party review, that our full end-to-end quality management system meets the highest standard for safety and quality.
“Certification to ISO 13485 demonstrates that Picomole has met an objective standard of excellence while complying with best practices and regulatory requirements. This certification also demonstrates that Picomole is delivering on its quality statement, “Our Commitment to Quality Saves Lives.” said Sandra Veenstra, Director of Quality Assurance and Regulatory Affairs at Picomole.
Picomole is poised to launch SohnoXB by end of year. If you are interested in learning more about our anticipated entrance into the market, you can contact us now through info@breathebiomedical.com.
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