The European Union Medical Device Regulation (EU MDR 2017/745) establishes strict requirements for medical devices entering the EU market. It covers technical documentation, clinical evaluation, post‑market surveillance, labeling, and quality management systems. Compliance is essential for CE marking and ongoing market access. Sterling Medical Registration offers end‑to‑end EU MDR consulting services. We guide manufacturers, authorized representatives, and importers through technical file preparation, QMS implementation, clinical evaluation, PMS activities, and process validation — ensuring devices meet EU standards while supporting patient safety and regulatory readiness.
Learn MoreThe U.S. Food and Drug Administration (FDA) regulates medical devices to ensure safety, effectiveness, and quality in the American healthcare market. Compliance requires manufacturers and importers to navigate complex processes such as 510(k) submissions, establishment registration, labeling standards, and post‑market reporting. Sterling Medical Registration provides comprehensive FDA consulting services that simplify this pathway. From preparing regulatory submissions and managing official correspondence to implementing quality systems and ensuring labeling compliance, we help organizations achieve and maintain FDA clearance with confidence.
Learn MoreA robust Quality Management System (QMS) is the foundation of medical device compliance worldwide. Regulatory frameworks such as EU MDR 2017/745, ISO 13485:2016, the FDA Quality Management System Regulation (QMSR), and Canadian requirements all demand that manufacturers establish and maintain documented processes to ensure product safety, performance, and consistency. Sterling Medical Registration provides end‑to‑end support in designing, implementing, and maintaining QMS programs tailored to global regulatory expectations. Our services cover system development, documentation, training, internal audits, and continuous improvement, ensuring your organization is fully prepared for notified body audits, FDA inspections, and Health Canada reviews. By aligning your QMS with international standards, we help you achieve compliance, streamline operations, and build trust with regulators, healthcare providers, and patients.
Learn MoreOur team specializes in supporting the design and development of medical devices tailored to meet global regulatory requirements. Properly managing the initial design and development stages is critical, as it directly impacts downstream Verification & Validation (V&V) activities, regulatory compliance, and ultimately, market success.
Learn MoreThe Israeli Medical Equipment Law, 2012 requires all medical devices to be registered in the Ministry of Health’s Medical Equipment Registry (AMAR) before they can be manufactured, imported, or marketed in Israel. The law is enforced by AMAR and includes strict requirements for registration, ISO certification, proper storage, and licensing, with penalties for violations. Fast‑track registration is available for devices already approved in recognized countries, and the registry is publicly accessible. Sterling Medical Registration provides comprehensive regulatory consulting in Israel, guiding manufacturers, importers, and distributors through AMAR registration, licensing, ISO certification, and compliance with the Medical Equipment Law. We support fast‑track registration for internationally approved devices, assist with documentation and storage requirements, and ensure your medical devices can enter and thrive in the Israeli market with confidence and full regulatory assurance.
Learn MoreSimplify your EU MDR compliance with expert EUDAMED support. Sterling Medical Registration provides end-to-end assistance for manufacturers, authorized representatives, and importers navigating the European Database on Medical Devices (EUDAMED). From account setup to device registration and ongoing maintenance, we ensure your data is accurate, compliant, and audit-ready.
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