NEW YORK (GenomeWeb News) – Miraculins today said that it has successfully completed a two-part ISO certification audit conducted by the BSI Group.
The Winnipeg, Manitoba-based biomarker-based diagnostics firm said that the audit recommended that the firm receive ISO 13485 certification. The company said the certification is a "critical regulatory and business plan milestone" as heads toward commercial launch of its PreVu Non-Invasive Skin Cholesterol test.
"Upon receipt of our ISO Certificate we will complete the required Health Canada and FDA filings, and the CE Mark Registration for the European Union and proceed to make PreVu commercially available to health care professionals and patients in North America and overseas in the very near term," Christopher Moreau, president and CEO of Miraculins, said in a statement.