Expert QA & RA Consulting for Medical Device Software
Quality assurance (QA) is the backbone of each medical device legal manufacturer. With a solid quality management system (QMS), that complies with the requirements of ISO13485 you will be able to bring your device to market and comply with regulatory requirements. MedQR Consulting BV offers full scope QA support to guide your business towards full QMS implementation and maintenance.
MedQR empowers medical device companies to achieve compliance, reduce risks, and enhance product quality
Complies with the U.S. FDA’s Quality System Regulation (QSR) for medical devices to ensure safety and effectiveness.
Focuses on optimizing processes to reduce waste, increase productivity, and maintain compliance.
Conducts thorough evaluations of internal processes or supplier practices to ensure they meet quality and regulatory standards.
Identifies discrepancies in your current quality system and provides guidance to align with EU MDR or FDA requirements.
Helps organizations get audit-ready through documentation, training, and process reviews to ensure successful outcomes.
A trusted consulting partner specializing in Quality Assurance (QA) and Regulatory Affairs (RA) for medical devices.
