Reprocessing and remanufacturing
Reprocessing of single-use medical devices (SUDs) is the practice of inspecting, cleaning, function testing, sterilizing and packaging so that they can be clinically and safely used again. Reprocessing of SUDs is regulated by the FDA. We satisfy all FDA regulatory requirements to reprocess medical devices and ensure that our reprocessed devices are substantially equivalent to original equipment devices.
The US FDA requires we obtain 510(k) clearance and comply with the same medical device regulations as original equipment manufacturers (OEMs), as well as comply with additional requirements
Additional requirements
- Reverse-engineer OEM devices
- Validate cleanliness and sterility
- Validate functional performance
- Validate replacement components as equivalent to new
510(k) clearance
- The reprocessor is able to clean and sterilize the device
- Functional performance of the reprocessed device is substantially equivalent to the predicate device
Substantial equivalence
Implies that two medical devices are equivalent in all characteristics that are of importance to the consumer including patient/physician safety, clinical performance, durability and reliability
How we ensure safety and quality
Design verification
Design validation
Reverse engineering devices
Cleaning and sterilization
Performance testing
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