Seriously, anyone can repair just about anything, as long as you have some basic skills, a few tools, hand-eye coordination, a garage with electricity, and YouTube. But should they? There is a dramatic difference between getting something working again and restoring a device to OEM form, fit, and function. Some in the repair industry attempt repairs using phrases such as, “Risk-Free Evaluations”. Others may say, “Send it in, and we’ll let you know” or “If we can’t repair it, we’ll offer an exchange”. Wouldn’t it be nice to know, upfront? Jedi Master Yoda, said it best. “Do, or do not. There is no try.”
Did you know, Innovatus only performs repairs on devices for which we have a process documented in our ISO 13485:2016 certified Quality Management System? There’s no bait and switch. Whether speaking, emailing, or chatting with our Customer Care team, you will always get an honest, upfront answer. Our team has references at their fingertips that enable them to say, Yes, we can”, or “No, not yet”. Not everyone in our industry can say the same, or is willing to do so.
On our website, the TotalRepair page and MRI Coil Solutions page show you the product models on which we offer full-repair capabilities. There’s no guessing. The Ultrasound Solutions page shows you the probe models on which we offer a variety of solutions. All of this data, and volumes more, is stored, maintained, and continually accessed in our Quality Management System.
Commitment to Quality
In the repair business, processes matter. They are the key to consistent, predictable, safe and effective outputs. The highest standard of quality assurance for medical device repairs can only come from companies that employ a quality management system certified to the latest ISO 13485 standard. Having an ISO 13845:2016 certified QMS identifies companies that demonstrate a consistent ability to provide medical devices and repair services which meet customer and applicable regulatory requirements.
What Matters Most
- Confidence that the probe repair or MRI coil repair is being performed by highly competent technicians whose training is documented.
- Assurance that employees are following documented industry best practices based upon established standards to ensure that repairs maintain standards that enable devices to perform to their original intended design.
- Certainty that all aspects of the repair are being addressed to enable an ultrasound probe or MRI coil to perform both safely and effectively.
- Security that controls are in-place that ensure accountability, assess and manage customer expectations, and enable continuous improvement.
- Knowledge that corners are not being cut during a repair process that can set a device up to perform inaccurately, or require additional repairs in the short term.
Why It Matters
More than ever, at this time in the medical device industry, there is so much at risk. The right-to-repair initiative could be considered a blessing or a curse, depending upon your point of view and how those you select as service providers approach repair. As patients, we trust healthcare institutions to provide us with access to timely, accurate information that could change, or even save, our lives. At a minimum, you should insist that the repair provider, that you call every time, employs an ISO 13485:2016 QMS.
For more information about ISO 13485:2016 certification processes, requirements and details, and compliance for sustainable repair services for 3D probes, TEE probes and standard probes, and MRI coil repairs, please email us at TedL@innovatusimaging.com.