What is the difference between remanufacturing and reprocessing?
Reprocessing typically refers to a process focused primarily on cleaning and hygiene. However, since reprocessors of single-use medical devices are increasingly regulated as manufacturers, and the regulated activity also comprises process steps that go beyond cleaning, many experts, including the Association of Medical Device Reprocessors (AMDR), refer to these activities as (medical) remanufacturing. We have adopted this designation.
Medical Remanufacturing is safe
We ensure that all our remanufactured products are restored to “as new” functional and safety standards and fully comply with EU regulatory requirements.
Our expertise: medical remanufacturing
Complex medical devices can only be remanufactured with state of the art remanufacturing processes. To ensure that a remanufactured device is substantially equivalent to the original product, our research and development group develops the technical specifications for each remanufactured device using advanced reengineering processes. The data required for the validation procedures is generated in our dedicated testing laboratories.
On this foundation we develop our medical remanufacturing procedures and validate these processes. This enables us to ensure the functional, hygienic and biological safety of our products and substantial equivalence to the original device.