Key Takeaways
- FDA registration and ISO 9001/13485 certification are verifiable. Check the FDA’s Establishment Registration database and IAF CertSearch yourself rather than relying on a provider’s claims.
- Technician training matters as much as company certification — ask about biomedical equipment training and device-specific troubleshooting experience.
- There’s no industry standard for repair turnaround time, so get a specific number before you commit.
- Ask what happens when a device can’t be repaired. Refurbished equipment should be an available option.
- Every repair should come back with post-repair testing and a documented service report covering the issue, inspection, work performed, and final testing.
As the cost of medical equipment continues to rise, choosing to repair medical devices is a smart, cost-saving decision. Your devices are expertly repaired, returned to you in a timely fashion, and ready for their important role in patient care.
The solution is finding a third-party repair partner you can trust. As you’re assessing repair providers, you’ll want to dig into their training, expertise, and documentation. It’s also important to understand their average turnaround time as you likely don’t have weeks to wait while a vital patient monitoring device is repaired.
Choosing the right repair partner saves you money on constantly buying brand-new devices. It’s a win-win for your budget, your schedule, and – most importantly – patient care.
The FDA also recognizes qualified medical device repair as safe and effective as long as your chosen repair partner adheres to quality management principles.
As you’re looking for a third-party repair partner, do your homework to find one that’s a good fit for your healthcare facility. We’ve put together this checklist of questions to ask before choosing a third-party medical device repair company.
Certifications and Training
1. Is the medical device repair facility FDA-registered?
While the FDA doesn’t officially approve facilities, Sage Services is listed with the FDA and adheres to a stringent set of ISO standards.
Sage Services Group has two facilities in South Carolina. While we can handle repairs at both locations, our Inman, South Carolina, facility is our primary repair shop. Our facilities are equipped with state-of-the-art tools and trained technicians ready to handle medical device repairs of all kinds.
While the FDA does not formally “approve” individual repair providers, you can search the Establishment Registration & Device Listing database. This database lists medical device manufacturers registered with FDA and medical devices listed with FDA.
The FDA chose not to impose additional regulatory requirements on third-party repair providers, recognizing that qualified repair adheres to quality management principles. Those are demonstrated through ISO certifications.
2. What certifications does the company have?
A qualified medical device repair company should hold ISO 9001 certification (general quality management) and ISO 13485 certification (quality management specifically for medical devices).
These certifications require annual audits and demonstrate the provider’s commitment to documented quality processes when servicing medical equipment and patient monitoring devices.
Here at Sage Services Group, we first earned our ISO 9001 in 2015. In 2018, we became dual certified with the addition of the ISO 13485 certification. We undergo an audit each year to maintain our dual certifications.
The independent auditor reviews our repair shops, equipment, processes, and quality control. At Sage, we bring in a third-party independent auditor so customers can trust our process and certifications.
When you’re interviewing a medical device service provider, be sure to ask about their certifications as well as the audit process. You want to know their evaluation is thorough and fair.
You can also verify a company’s ISO certifications by searching for the company name in this online IAF CertSearch database.
3. What kind of training or education do the repair technicians receive?
At minimum, a qualified repair tech should have biomedical equipment training, basic electronics knowledge, electrical safety skills, device-specific troubleshooting experience, and be able to document their work.
At Sage Services, we hire the best technicians in the business to handle your medical device repairs. Not only do our techs come to us with a service background and training, but we also provide ongoing education, training, and certification opportunities.
For example, every two years, our technicians are recertified to the IPC-7711 and IPC-7721 endorsement. This widely used standard offers a wealth of industry-approved techniques in rework, modification, and repair of electronic assemblies.
This level of training allows us to repair devices other companies may not be qualified to handle.
Customer Service
4. What is the average turnaround time for device repairs?
At Sage Services Group, our normal turnaround time is 5 to 7 business days.
Across the medical device repair industry, there is no standard turnaround time. It often varies based on the device type or availability of parts. Fortunately at Sage Services, our trained technicians are adept at diagnosing an issue and getting it repaired quickly.
Our average turnaround time of 5 to 7 business days is a big plus for our customers who need their devices repaired and in excellent working condition fast.
5. What happens if my device can’t be repaired?
If your medical device can’t be repaired, ask if the third-party repair partner buys devices or offers refurbished options.
Our technicians are excellent, but every once in a while they encounter a device that is beyond repair. We sell refurbished medical devices at competitive prices. Purchasing refurbished equipment is a smart choice for hospitals and healthcare facilities who want to maximize their budgets.
Our refurbished equipment is fully repaired, inspected, and tested in our state-of-the-art repair facilities. Each refurbished device meets today’s standards and is backed by a full warranty.
If your device can’t be repaired, consider refurbished equipment. We typically have several items stocked and ready to ship, including telemetry transmitters, bedside monitors, transport monitors, and EKG machines.
6. Do you have an automated call center or is there an actual person in your office who answers the phone?
We have real people at our offices who pick up the phone and can answer your questions.
Customer care is at the core of our work. We have team members who answer the phone and work directly with our customers to help them get what they need.
We also have a dedicated sales team. Each customer has access to a sales representative they can call with any questions or concerns. Our sales representatives work closely with customers in their dedicated territory. They can even pick up devices from your medical facility or hospital and ship them to our repair shop. Customers truly appreciate that time-saving service.
Documentation and Testing
7. After a medical device is repaired, does it go through any kind of testing?
Once a device is repaired, it’s tested to ensure it’s working properly.
At Sage Services Group, our technicians diagnose and repair your patient monitoring device. Then each device is thoroughly tested to ensure it’s working and no additional repairs are needed. With our rigorous process, you feel confident your device is fixed and you won’t have to deal with additional issues or breakdowns.
8. Do you provide a repair report or documentation?
Each repair should include a detailed report documenting the issue, actions taken, and final testing.
At Sage Services Group, we send each repair customer a detailed service report. The report includes a description of the reported issue and customer information.
The technician notes details on the initial inspection to confirm customer complaint and damage. The report includes a list of services performed to get the device back in working condition. And it outlines the final inspection process and testing details.
Use this checklist the next time you’re evaluating a repair partner — whether that’s Sage or someone else. You deserve a provider who can answer every question on the list.
–———-
Is third-party medical device repair approved by the FDA?
The FDA doesn’t formally “approve” individual repair companies — but it does maintain an Establishment Registration & Device Listing database where you can verify a provider is registered. The FDA has chosen not to impose additional regulatory requirements on third-party repair providers beyond this, recognizing that qualified repair work adheres to quality management principles typically demonstrated through ISO certification.
How do I verify a repair company’s ISO certifications myself?
You can search the company name directly in the IAF CertSearch database to confirm active ISO 9001 and ISO 13485 certifications.
What should I expect for turnaround time on a device repair?
There’s no industry-wide standard — turnaround time varies by device type and parts availability. Ask any potential partner for their average turnaround time upfront so you can plan around it.
What happens if my device turns out to be unrepairable?
Ask whether your repair partner offers refurbished equipment as an alternative. A good partner should have options ready.
Will I get documentation showing what was actually done to my device?
You should. A thorough repair report should include the original reported issue, findings from the technician’s initial inspection, a list of services performed, and results of final testing.
