Revolutionize Medical Device Licensing with Sustainable End-of-Life Solutions
Are you a medical device licensing consultant looking for innovative and sustainable solutions for end-of-life management of medical devices? IoMT Solutions is transforming the medical device industry by providing environmentally responsible and compliant end-of-life solutions.
Code of Federal Regulations Title 21
Title 821.25, 3, viii – Medical Device Tracking Requirements states a manufacturer must maintain the following records: “If and when applicable, the date the device was returned to the manufacturer, permanently retired from use, or otherwise permanently disposed of.”
Until recently, Title 821.25 was broadly overlooked during the licensing process of medical devices.
That’s going to change.
According to FDA.gov, “the regulation provides the framework that all manufacturers must follow by requiring that manufacturers develop and follow procedures and fill in the details that are appropriate to a given device according to the current state-of-the-art manufacturing for that specific device.” That includes disposal.
With the growth of more connected devices and the global e-waste problem, the FDA will be enforcing this requirement to ensure that manufacturers remain responsible for medical device end-of-life solutions. ISO 13485:2016 has also evolved in the last ten years to include the international standard specific for medical device quality management systems. This would harmonize quality management system requirements for FDA-regulated devices with requirements used by the International Medical Device Regulators Forum (IMDRF).
One of IMDRF’s main objectives for 2025 is to strengthen post-market surveillance for medical devices and implement regulatory life cycle processes.
Offering an end-of-life solution that understands these regulations and already has systems in place to record, track, destroy, and certify the secure disposal of obsolete medical devices will strengthen your consulting business.
Why Partner with Us?
1. Sustainability at Heart
We believe in responsible healthcare. By partnering with us, you align your consultancy with a sustainable approach to medical device lifecycle management. Our solutions reduce environmental impact while ensuring compliance with environmental and privacy regulations.
2. Regulatory Expertise
Our team of experts is well-versed in the complex world of medical device disposal regulations. By joining forces, you can tap into our knowledge and resources to navigate the licensing landscape efficiently.
3. Market Differentiation
Offering sustainable end-of-life solutions can set you apart in a competitive market. Partnering with us allows you to expand your service portfolio and attract clients who prioritize environmentally friendly practices.
4. Revenue Opportunities
Our partnership opens doors to new revenue streams for yourself. You can earn referral fees, or consultancy fees by collaborating with us on projects that require licensing and end-of-life solutions.
Our End-of-Life Solution
Device manufacturers need to have mechanisms to track and locate devices while they are in use, as well as once they are decommissioned and disposed of. Building this end-of-life solution into the manufacturing process is critical because:
- Regulations dictate that a manufacturer must maintain records and location of a device during it’s lifespan
- Keeping used devices off the market helps manage extended (and often uncontrolled) product liability, as well as protecting the value of new devices.
- There are environmental laws and regulations about the disposal of electronics.
IoMT Solutions provides secure and trackable full chain of custody of medical devices. We provide all regulatory documentation to remain compliance with all state and federal manufacturing, privacy, and disposal laws.
IoMT Solutions works with large and small medical device manufacturers to dispose of defective devices, customer returns, and excess inventory. We take returns directly from end users, we pick them up from medical facilities, or from the manufacturer, and provide end-to-end reporting and certifications.
Partner Benefits
1. Comprehensive Training
We provide training and resources to empower our partners with in-depth knowledge of our solutions and the regulatory landscape of electronics disposal.
2. Marketing Support
Access to marketing materials, co-branded content, and support for client outreach to help you promote your partnership with us effectively.
3. Collaborative Projects
Engage in collaborative projects where your expertise complements our end-of-life solutions, delivering exceptional value to clients.
Ready to take your medical device licensing consultancy to the next level? Join us in shaping the future of responsible healthcare. Partner with IoMT Solutions and help medical device manufacturers navigate the complex world of regulations while promoting sustainability.