MDR Compliance with Qserve
With expertise in MDR regulatory strategy, quality assurance, and clinical evaluation, Qserve offers a comprehensive suite of services to help manufacturers meet compliance standards effectively. Our services include:
Regulatory Strategy & Planning: Develop a tailored compliance strategy that aligns with the MDR’s unique requirements.
Clinical Evaluation and PMCF (Post-Market Clinical Follow-Up): Gain support in meeting clinical evidence requirements through systematic data collection and reporting.
Quality Management System (QMS) Implementation: Establish an MDR-compliant QMS, including CAPA and risk management practices.
Technical Documentation Preparation: Assemble comprehensive technical files that meet EU MDR specifications.
Regulatory Due Diligence & Gap Analysis: Identify compliance gaps and implement corrective actions with expert guidance.
Training: Prepare your team for MDR success with virtual and/or on-side MedTech training.