Reconext is a global R2-certified recycler dedicated to reducing environmental impact through responsible reuse, repair, and recycling solutions. With operations across multiple sectors, Reconext partners with leading technology companies to extend product lifecycles, reduce waste, and support sustainability. Their commitment to innovation and environmental stewardship enables them to meet the evolving needs of customers while contributing to a greener planet.
The Situation
In early 2025, one of Reconext’s largest customers requested the refurbishment of medical devices. The customer had an extremely tight deadline and required Reconext to achieve compliance with ISO 13485, the international standard for medical devices, while also ensuring continued FDA compliance as part of their supply chain.
Failure to meet this requirement could have resulted in significant penalties, loss of customer trust, and disruption of service deliverables.
The Solution
TMAC partnered with Reconext beginning in February 2025 to rapidly design and implement a compliant QMS. The solution included:
- Development of a customized Quality Management System (QMS) specifically designed for Reconext’s operations.
- Development of personnel knowledge in medical device regulatory requirements and organizational responsibilities.
- Integration of specific customer requirements and service delivery metrics into the QMS.
- Internal assessments to prepare the team for the initial ISO 13485 certification audit
By August 2025—just six months later—Reconext was recommended for certification, meeting their customer’s deadline. This rapid achievement was made possible through MedMMAP funding, which supported a portion of the project costs.
The Results
The Results
Enhanced internal competency and awareness of medical device QMS requirements
Achieved ISO 13485 certification with zero findings in record time
Direct cost savings of over $28,000
Retained customer sales and service delivery estimated at over $1,000,000
“We did it! We have been recommended for ISO 13485 certification. Big thanks to all of you – TMAC Team.”
Marlon Cubero (Director – Quality & Facilities)
