Quality throughout our organisation is paramount for success; it minimises clinical risks and improves the delivery of services.
Insignia has been successfully and continuously assessed for many years and are proud to be one of the first UK PACS & VNA vendors to have been certified to the ISO 13485 standard for Medical Devices.
Highly Recommended PACS Supplier
Insignia have received the Highly Recommended PACS Supplier award in an independent report by peer60. Insignia were the only supplier to achieve top marks in the ‘Can your current PACS supplier help you achieve your goals’ category, peer60 reviewed that “Insignia, scored 100% among its customers as a partner who can help them meet their goals. Insignia stands as the perfect example that a well-run company, when focusing on excellence as a specialist, can give large enterprise suppliers a run for their money.”
ISO 9001 : 2008 specifies requirements for a quality management system where an organisation needs to demonstrate its ability to consistently provide products that meets customer and applicable statutory and regulatory requirements, and aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
ISO 13485 : 2003 specifies requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
CE Marked Product
A CE mark ensures that a product is assessed before being placed on the market and meets EU safety, health and environmental protection requirements.
Insignia Medical Systems Ltd DICOM Conformance Statement: The Insignia Enterprise PACS, Breast PACS, Disaster-Recovery PACS and Vendor Neutral Archive (VNA) products share a common set of application components which constitute their DICOM interface to other systems. These components reside on the Insignia Departmental Server system component; hence this Conformance Statement is versioned in accordance with the Departmental Server. Each product also contains a central database and various short-term and long-term storage nodes with which the DICOM components interact. Each may also contain other system components, but these are not relevant to this document.
Health Level Seven International is one of several American National Standards Institute (ANSI) - Accredited Standards Developing Organizations (SDOs) operating in the healthcare arena. Most SDOs produce standards (sometimes called specifications or protocols) for a particular healthcare domain such as pharmacy, medical devices, imaging or insurance (claims processing) transactions. Health Level Seven's domain is clinical and administrative data.