Spectral Medical Announces that its wholly owned subsidiary Dialco Medical has received MDSAP certification
- MDSAP is the highest quality and regulatory standard in the medical device industry
TORONTO, Nov. 24, 2020 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late stage theranostic company advancing therapeutic options for sepsis and septic shock, as well as commercializing a new proprietary platform targeting the renal replacement therapy market, today announced that its wholly owned subsidiary, Dialco Medical Inc. (“Dialco”) received its Medical Device Single Audit Program (“MDSAP”) certification for “the design, manufacture, installation and service of equipment for extracorporeal blood purification and its related disposable” under ISO 13485 for Canada (Medical Devices Regulations – Part 1- SOR 98/282) and United States (21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807 (Subparts A to D), 21 CFR 821).
MDSAP allows the conduct of a single regulatory audit of a medical device manufacturers quality management system to satisfy the requirements of multiple regulatory jurisdictions or authorities to enable appropriate regulatory oversight of medical device manufacturers’ quality management systems while minimizing regulatory burden on the industry. The program was developed by the International Medical Device Regulators Forum and currently representatives from The Therapeutic Goods Administration in Australia; Brazil’s Agência Nacional de Vigilância Sanitária; Health Canada Canadian Medical Device Regulations; Japan’s Ministry of Health, Labour and Welfare and Pharmaceutical and Medical Devices Agency, and the U.S. Food and Drug Administration, Center for Devices and Radiological Health participate in the program.
“On Dialco’s continued commercialization path, MDSAP and ISO 13485 certifications represent important milestones. Not only does certification through these programs validate our ongoing commitment to maintaining the highest quality assurance standards within the medical device industry, but MDSAP certification is also a Health Canada mandated requirement to sell medical devices in Canada,” said Dr. Gualtiero Guadagni, President of Dialco. “Additionally, Dialco’s receipt of its own MDSAP certification supports Dialco’s continuous pathway of achieving a fully independent operating structure."
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