Leading European MedTech startup in radiology AI solutions, AZmed, has received the Medical Device Single Audit Program (MDSAP) certification, which guarantees that the company develops and supplies safe, effective, and regulatory-compliant medical imaging solutions. This certification ensures that AZmed meets the medical device regulations of the United States, Brazil, Australia, and Canada.
Currently, the biggest challenge in the industry for medical device manufacturers is regulatory compliance since every country has its own regulations for market approval, meaning that companies have to go through several audits that are usually time-consuming and complicated. However, MDSAP makes it easier by providing a single audit.
This certification builds on top of AZmed’s Quality Management System (QMS) and ensures that the company is compliant with international standards relevant to its operations. MDSAP is proof that AZmed adheres to the best practices in the design and development of its radiology AI solutions, while at the same time demonstrating the company’s commitment to quality and patient safety. Moreover, it minimizes the time that would have been used in conducting separate audits for different countries, thereby improving operational efficiency as well as meeting all regulatory requirements.
The MDSAP certification is a globally recognized program created to streamline multiple countries’ regulatory requirements into one. By implementing international standards, AZmed enhances its QMS to meet the requirements of international medical device regulations, which reassures that the company meets the required quality and safety standards. The startup has added another accolade to its portfolio, having earlier obtained ISO 13485 certification and regulatory approvals such as CE marking and FDA clearance for its leading AI fracture detection solution. More than 2,500 healthcare facilities across 55+ countries have adopted AZmed’s solutions, making this certification an essential step in its commitment to offering reliable and clinically validated medical imaging solutions to enhance radiology workflows and support healthcare professionals worldwide.
To find out more about AZmed, please visit www.azmed.co.
