Reprocessing of Single-Use-Devices (SUD’s)
Before medical devices can be reprocessed and reused, a third-party or hospital reprocessor must comply with the same requirements that apply to original equipment manufacturers, including:
- Submitting documents for premarket notification or approval
- Registering reprocessing firms and listing all products
- Submitting adverse event reports
- Tracking devices whose failure could have serious outcomes
- Correcting or removing from the market unsafe devices
- Meeting manufacturing and labeling requirements
Since its origination, Realistic Quality Solutions LLC has been providing quality and regulatory advice and consulting to The Association of Medical Device Reprocessors (AMDR) and their members.
RQS Inc., has helped draft reprocessing language for the European Medical Device Directive and has developed an initial matrix of requirements for various regulatory authorities. RQS works with reprocessors to help them comply with U.S. and international quality standards like ISO-13485, obtain 510(k) clearances, and address validation issues.
If you are a third-party reprocessor or are considering reprocessing of a medical device, contact RQS and let us assist you with the necessary quality and regulatory requirements to attain and maintain your necessary level of quality and product compliance. In this way you can ensure the highest possible standards of regulatory and professional conduct.