Quality & Regulatory
By integrating compliance, precision, and transparency, RexMed delivers confidence to OEMs and healthcare partners seeking dependable contract manufacturing in the medical device industry.
Our Quality Policy
RexMed operates under a certified Quality Management System in accordance with ISO 13485:2016 (FM 82718), FDA 21 CFR Part 820, and NOM-241-SSA1-2021. Our system ensures that medical devices are manufactured with consistency, safety, and regulatory integrity.
Our QMS spans the full lifecycle of Class I and II medical devices, including cleanroom manufacturing (ISO Class 7 and 8), medical grade extrusion, labeling, packaging, and sterilization oversight. Procedures are in place for risk management, training, document control, complaint handling, and CAPA.
Process validation through IQ, OQ, and PQ is applied where required, supporting full traceability and documentation aligned with international standards. RexMed’s facilities in Ciudad Juárez and El Paso Tx are strategically positioned to serve both U.S. and Mexican markets under dual regulatory frameworks.
RexMed maintains a structured, audit-ready environment that supports internal assessments and client or regulatory inspections. Our focus on continuous improvement ensures adaptability to evolving requirements while reinforcing product reliability.
