Ryder’s top performance in FDA Inspection for Class III Medical Devices
Class III medical devices sit at a high regulatory threshold for risk. These are the products that sustain life or support critical functions, meaning the standards they must meet are correspondingly tough. The US FDA’s Premarket Approval (PMA) process is the most stringent process and is required before launch of most Class III devices to the U.S. market. Passing the Pre-Approval Inspection for a PMA requires not just excellent documentation, but daily operational excellence.
Uncompromising standards.
SetPoint Medical develops implantable neuroimmune modulation devices, most notably the newly FDA approved SetPoint System, for treating chronic autoimmune diseases such as rheumatoid arthritis.
As one of the manufacturing partners entrusted with the production of the SetPoint System, Ryder’s most recent FDA Pre-approval inspection (PAI) resulted in a successful outcome: minor observations, no corrective actions, and no remediation required. This is an extraordinary result in the industry and it confirms Ryder’s ability to deliver high-performance electronics with uncompromising quality control and vertically integrated production.
Ryder Electronics (Shenzhen) Ltd. is now officially listed on the FDA’s Establishment Registration & Device Listing database as a certified contract manufacturer for Class III medical devices. This listing confirms our role in the production of the FDA-approved SetPoint System and reflects the successful outcome of our Class III Pre-Approval Inspection (PAI).
What this means for customers.
Our inspection success is more than a regulatory milestone; it is evidence that Ryder consistently operates at the highest standards of precision and compliance. This directly benefits our customers through:
- Uncompromising Quality & Compliance: ensures consistent quality and reliability, minimises the risk of defects, and demonstrates alignment with evolving global requirements.
- Accelerated Market Access: Leverage our well-established processes and proven regulatory expertise to streamline your submission and approval pathway. Partnering with a certificated manufacturer like Ryder helps you reach the market faster, while significantly reducing both regulatory and operational risk.
- Supply Chain Stability and Transparency: Benefit from robust systems for end-to-end traceability and accountability. Our systems ensure supply chain integrity, provide rapid issue resolution, and strengthen long-term reliability for your critical devices.
A commitment to excellence.
Ryder’s ISO 13485 certification and proven track record across the full spectrum of US FDA and EU Medical Device Regulation regulatory pathways demonstrate our deep, long-term commitment to quality. For OEMs, this means a partner that not only understands compliance, but also ensures that quality is embedded in every stage of production.
Our FDA inspection outcome is the clearest possible signal that customers can rely on Ryder to uphold the same standard of excellence that regulators demand and patients deserve.
