Bifogade filer
Devyser receives MDSAP certification for Brazil
Prenumeration
Beskrivning
| Land | Sverige |
|---|---|
| Lista | First North Stockholm |
| Sektor | Hälsovård |
| Industri | Medicinteknik |
Devyser Diagnostics AB announces today that it has received Medical Device Single Audit Program (MDSAP) certification for its quality management system (QMS) for both Devyser assays and software in Brazil.
The MDSAP certification for Brazil complements the company's existing certificates in the United States and Canada, reinforcing Devyser’s commitment to meeting the highest standards of quality, safety, and regulatory compliance across multiple jurisdictions. With MDSAP certification for Brazil, the company is well-positioned to expand its reach and impact in the Latin American region.
MDSAP certification can potentially expedite the timeline for the commercialization of regulatory-approved products.
“Achieving another MDSAP certification confirms our ongoing commitment to maintaining the highest quality assurance standards for our products and accompanying software. This certification not only demonstrates our commitment to regulatory compliance, but also strengthens our position in the global marketplace, enabling us to better serve the needs of our customers,” said Fredrik Alpsten, CEO of Devyser.
Devyser is partnered with several distributors in Brazil including Thermo Fisher Scientific and Biometrix.
MDSAP is a regulatory initiative designed to streamline and harmonize the audit process for medical device manufacturers, enabling a single audit to satisfy the QMS requirements of participating regulatory authorities, such as FDA, ANVISA, Health Canada, among others.