Jacksonville, FL — August 1, 2016, ASPYRA, LLC (ASPYRA), a market leader in Picture Archiving and Communication System (PACS), released news today that they have received ISO 13485 Certification on AccessNET and MedVIEW. ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes, is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry throughout every step of a product’s life cycle, including service and delivery.
Certification is not a requirement of the ISO 13485 standard, however, third-party certification can demonstrate to customers and regulators that ISO 13485 requirements have been met. To find out more about the standard, you can find a link on ASPYRA’s Imaging Solutions page www.aspyra.com/imaging-solutions.
ASPYRA’s Quality System, in place for over 10 years, has been certified by British Standards Institution (BSI) notified body 0086. The certification process involves audits of the company’s internal practices and policies, documentation, and verification that appropriate harmonized standards are being followed.
“ASPYRA has always been committed to ensuring development and implementation of the highest quality products and, as such, follows necessary standards such as ISO 13485, ISO 14971 for Risk Management, and Federal regulations such as the 21 CFR 820 and others” states Gary Bennett, ASPYRA President. “As a prelude to the company’s application for CE mark for the European Union, we have had notified body BSI review our processes. This just helps confirm for customers that our products are made to the highest quality standards.”