Quality & Regulatory Compliance Statement

Electro Range MFG Co. (ERMC) is fully committed to maintaining the highest standards of quality and regulatory compliance in the design, manufacture, and distribution of electrosurgical instruments. Our facility operates under a certified Quality Management System in accordance with ISO 13485:2016, ensuring that all processes are strictly controlled and documented.

All ERMC products are designed and manufactured in compliance with the European Medical Device Regulation (MDR 2017/745) and bear the CE mark where applicable. Sterile single-use products are processed through our in-house sterilization facility, fully compliant with ISO 11135.

Independent audits by SGS, as well as sustainability verifications by SMEDA and SEDEX, further validate our commitment to quality, safety, sustainability, and ethical business practices. ERMC continuously invests in training, technology, and infrastructure to maintain a regulatory framework that meets and exceeds international expectations.