Reprocessing of single use devices (SUDs) is regulated by the FDA. Stryker’s Sustainability Solutions must obtain 510(k) clearance and comply with the same medical device regulations as Original Equipment Manufacturers (OEMs), as well as comply with additional requirements:
- Reverse-engineer OEM devices
- Validate cleanliness and sterility
- Validate functional performance
- Validate replacement components as equivalent to new
The U.S. FDA and substantial equivalence
The U.S. FDA sets stringent quality and safety standards for the reprocessing industry that assure devices are substantially equivalent to the original device. We satisfy all FDA regulatory requirements to reprocess medical devices and ensure that Stryker’s reprocessed devices are substantially equivalent to original equipment devices.
- In addition, we warrant our reprocessed and remanufactured devices and carry a liability policy similar to that of other original equipment manufacturers.
How we ensure safety and quality
Each device is tested for proper functionality and inspected to ensure performance is equivalent to that of the OEM
At Stryker, quality is first in everything that we do. We are driven to make healthcare better for our customers by providing innovative products and services that meet regulatory requirements through our effective quality system.
At a glance
105+ cleared 510(k)s