ASPYRA has announced it has received a CE Mark on its picture archiving and communication system (PACS) products, including MedVIEW with AccessNET.
The company’s PACS products were evaluated by BSI Group (notified body number 0086) to validate that the products and processes used meet the requirements for CE mark, a quality certification widely used in the EU marketplace.
CE mark requirements cover every aspect of the product including planning and development, risk management, service, labelling, complaint handling, customer communication, and reporting of any adverse events among other requirements. Validation processes involving third party audits of the company’s internal practices and policies, documentation, and verification that appropriate European and US standards are being followed.
ASPYRA’s president Gary Bennett said: "ASPYRA has always followed standards including ISO 13485, ISO 14971:2012 for risk management, and US Federal regulations such as the 21 CFR 820 and others from the Food and Drug Administration (FDA), Health and Human Services (HHS), et al.
"The CE mark checks against additional standards such as Medical Device Directive 93/42/EEC, MEDDEV 2.12-1 (Medical Devices Vigilance System), and EN62304:2006 (Medical Device Software Life Cycle). The CE Mark is a valuable tool for customers, particularly in conjunction with the ISO 13485 certification, giving them the utmost confidence that our products are made to the highest quality standards."