EHC delivers：
US FDA Consulting Services: • Product classification • Device registration and listing • 510(k) premarket notification • Establishment registration and annual renewal • Assistance with U.S. FDA Small Business qualification • Pre-Submission (Q-Sub) preparation • GUDID registration • Quality Management System Regulation (QMSR) mock audit and FDA inspection support • 513(g) request for device classification • Medical Device Labeling Review | UK/EU MDR Consulting Services: • Product classification • MDR technical documentation preparation • ISO 13485 system training and mock audit • EUDAMED registration • Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER) • Introducing EU/UK In-country representation • UK Technical Document Preparation • UK Device Registration |
Canadian Device Registration Consulting Services: • Canadian medical device registration • MDSAP system coaching and mock audit | |
Regulatory & Product Standards Training Services: • Customized training programs • Pre-market and post-market regulatory requirements for the U.S., EU, and Canada • ISO 13485 internal auditor, QMSR and MDSAP system training • Product general electrical safety standard IEC 60601-1 training | Agency Testing Services: • Connects clients with accredited third-party laboratory resources, providing a single, managed pathway from testing requirements to final report delivery. |
Recognized as specially-appointed experts within leading industry associations, EHC brings over 20 years of deep technical leadership to the Cosmetics, Medical Devices, OTC Drugs, Household Products, Toys and Chemical Products sectors.
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