Our team helps you establish and implement a robust Quality Management System aligned with ISO 13485 and EU MDR requirements, ensuring consistent compliance and operational excellence.
We prepare and maintain your EU MDR Technical File, ensuring all required evidence, risk assessments, and supporting documentation are complete and compliant for CE marking.
Simplify EU MDR compliance with Sterling Medical Registration. We provide expert EUDAMED support for manufacturers, authorized representatives, and importers. From account setup to device registration and ongoing maintenance, we ensure your data remains accurate, compliant, and audit ready.
Learn MoreWe support the preparation of Clinical Evaluation Reports (CERs) and guide you through PMS activities, including PSUR, SSCP, and PMCF, to demonstrate ongoing safety and performance of your devices.
Learn MoreWe assist in designing and reviewing labels, symbols, Instructions for Use (IFUs), and packaging to meet EU MDR standards while remaining clear and user-friendly for healthcare professionals and patients.
Our experts provide guidance on product test assessments, design and development strategies, and validation processes to ensure your devices meet EU MDR performance and safety requirements.
PRRC stands for Person Responsible for Regulatory Compliance, a role defined under EU MDR 2017/745 and IVDR 2017/746. Every manufacturer placing devices on the EU market must designate a qualified individual with regulatory expertise to oversee compliance.
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