ISO 13485:2012

ISO

ISO 13485:2012 Certified

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 13485:2012 details specific requirements for a quality management system where organizations 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 13485:2012 standard is globally recognized as the best quality practices from organizations within the medical device industry.

Registration was a goal for Realtime, although it was recognized that the pursuit of quality provides benefits well in excess of gaining registration. Robust, quality-imbued processes add immense value to the development, manufacture, distribution and to both the internal and external customer.

ISO 13485:2012 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 the customer, internal quality and regulatory requirements. Due to the nature of the 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.