Innovatus Imaging is proud to announce and welcome Les Edsall as the Company’s Director of Quality and Regulatory and General Manager of Pittsburgh MRI Coil Center of Excellence.
A probe is a sophisticated, Class II medical device with a tremendous amount of acoustic and materials science and technology integrated into the design and construction. As an OEM made the original probe, the complex part for an ISO is to determine how to restore the probe to OEM form, fit and function. Repair service providers with an ISO 13485:2016 certification specific to medical devices, have a much more solid foundation for repairs than those without. To achieve optimal quality in repairs, this certification is a bare minimum customers should look for when choosing a repair provider. Having a medical device manufacturing background and philosophy is another distinction that can set providers apart. Companies with a manufacturing mindset tend to look at each device from a holistic perspective which drives everything associated with the repair to a higher standard.