Realtime Technologies’ QMS has been recertified to ISO 13485:2003 Quality Management Standard. This demonstrates Realtime’s ability to provide medical equipment and related services that consistently meet customer requirements and regulatory requirements applicable to medical equipment and related services.
ISO 13485:2003 details specific requirements for a quality management system where organisations need to demonstrate their ability to provide medical equipment and related services that consistently meet customer requirements and regulatory requirements applicable to medical equipment and related services. The ISO 13485:2003 standard is globally recognised as the best quality practices from organisations within the medical device industry.
Registration was a goal for Realtime, although it was recognised that the pursuit of quality provides benefits well in excess of gaining registration. Robust, quality-imbued processes add immense value to development, manufacture, distribution and to both the internal and external customer.
ISO 13485:2003 helps Realtime Technologies to provide a structure for implementation of requirements. It ensures the achievement of these planned results and the maintenance and effectiveness of those processes in relation to customer, internal quality and regulatory requirements. Due to the nature of medical equipment, safety is one of the principal requirements.
Realtime Technologies is an electronics contract manufacturer and services provider. With a reputation for quality and flexibility, we design and build products for Secure Payment Systems, Aerospace, Automotive, and Medical sectors. Comprising of facilities in Ireland, Czech Republic, US, Slovakia, and offices in the Far East and South America, we provide the most cost effective and efficient route to bring your product onto the global market. From single item prototypes to medium and high volume quantities, Realtime can deliver the trusted experience and expertise needed to drive your product development and business growth forward.