Frequently Asked Questions About Service Options (ISO vs. OEM)
Originally published in TechNation’s Roundtable: ISO & OEM Service Options, April 01, 2025.
TechNation, a publication focusing on medical equipment service professionals, recently conducted a roundtable conversation between industry experts to explore differences between third-party service providers and original equipment manufacturer (OEM) service for medical equipment. ReNew’s Assistant Biomedical Manager JL Morgan, CBET, answered TechNation’s questions about how third-party providers provide quality service comparable to OEMs.
Q: What do you believe are the primary differences between services provided by OEMs and independent third-party service organizations?
Morgan: OEMs often have longer turnaround times for repairs and can only service their equipment. In contrast, third-party service organizations offer faster response times and support a wide range of equipment from multiple OEMs. This flexibility simplifies maintenance and streamlines service management for end users, reducing downtime and providing a more efficient, cost-effective solution.
Q: How do independent third-party service organizations ensure the same level of quality and reliability as OEM services?
Morgan: The standard for ReNew Biomedical is for our technicians to follow OEM service manuals to ensure repairs meet OEM standards. ReNew technicians also use calibrated test equipment and follow the same testing procedures and documentation as released by the OEM to test to the same standards. Additionally, many OEMs provide service training for third-party providers, equipping them with the necessary knowledge and skills to maintain and repair equipment at the same level of quality as the OEM.
Q: What advantages do third-party service organizations have over OEM services in terms of cost-effectiveness and flexibility?
Morgan: Third-party organizations can significantly reduce service costs by using aftermarket and refurbished parts. In contrast, OEMs are limited to using only their own manufactured parts, often leading to higher expenses. The usage of refurbished parts allows third-party providers to deliver service beyond the point when an OEM declares a device is end-of-life.
Q: Are there any regulatory or compliance challenges that independent third-party organizations face compared to OEMs when servicing medical devices? How do you address these challenges?
Morgan: Since the FDA does not currently regulate servicing activities, ReNew has achieved and sustained ISO 13485 certification to ensure compliance with industry best practices. This standard focuses on quality management for medical devices, emphasizing regulatory requirements, risk management, and consistent service quality, helping third-party organizations maintain high standards and reliability in their operations. Beginning in 2026, the FDA is also aligning their QMS Reg (Quality Management System Regulation) with the ISO 13485 standard, so the expectations of ISO 13485 certification will mirror the expectations that the FDA places on OEMs for the maintenance, repair, and servicing of their own devices. It’s important for device users to research their service providers, and they should expect that proficient service providers will also maintain ISO 13485 certification.
Q: What impact do parts availability and sourcing have on third-party service offerings versus OEM services?
Morgan: In most cases, ReNew seeks to purchase parts directly from the OEM. Alternatively, a third-party service organization can source aftermarket or refurbished parts to prevent delays in repairs or service. This flexibility allows for faster turnaround times, ensuring equipment remains operational without waiting for OEM-supplied components, which may have longer lead times. ReNew maintains the responsibility for ensuring that any third-party or refurbished parts do not impact the performance of the device.
Q: Are there any misconceptions that you believe need to be addressed about the value of third-party service organizations compared to OEM service providers?
Morgan: Many assume OEMs provide better service than third-party service organizations, but third-party organizations like ReNew employ highly trained experts, sometimes former OEM technicians. Another misconception is that third-party organizations use inferior parts, yet many offer high-quality, certified, or even OEM components. Third-party organizations can also provide faster response times, flexible scheduling, and vendor-agnostic expertise. While cost savings are a benefit, ReNew offers more than just affordability— we deliver customized solutions, extended support for legacy equipment, and, in some cases, more flexible service options than OEMs.
