The reprocessing and reuse of single-use medical devices require third-party or hospital reprocessors to meet the same stringent regulatory standards that apply to original equipment manufacturers (OEMs). At Realistic Quality Solutions (RQS), we provide comprehensive regulatory guidance, ensuring compliance with FDA, EU MDR, ISO 13485, and global market requirements while addressing validation, risk mitigation, and post-market surveillance strategies.

Medical device reprocessing is highly regulated, requiring adherence to strict safety, efficacy, and documentation standards before reprocessed devices can be lawfully marketed. RQS ensures full compliance across key regulatory frameworks via:

1. FDA marketing clearances and approvals
2. Facility Registration & Product Listing Compliance
3. Adverse Event Reporting & Post-Market Surveillance
   Device Tracking & Risk Management
4. Manufacturing Standards & Labeling Compliance

Since its founding, Realistic Quality Solutions LLC (RQS) has been a trusted regulatory and quality assurance partner for medical device reprocessors. Our industry contributions include
 

1. Advising the Association of Medical Device Reprocessors (AMDR) and its members on global compliance strategies.
2. Drafting key reprocessing language for the EU Medical Device Regulation (MDR).
3. Developing a regulatory matrix detailing compliance requirements across multiple international jurisdictions.
4. Providing regulatory consultation on ISO 13485 implementation, FDA marketing clearances and approvals, and validation strategies for reprocessed devices.