Become part of our Quality & Regulatory Team and help us in building Regulatory Compliance for European Union & USA.
• To prepare Technical Files in compliance with IEC 61010-1, IEC 61010-2-012, IEC 61010-2-08, IEC 61326.
• To provide Support in preparing Technical Files in compliance with, RoHS and WEEE, and REACH.
• To provide Support in making compliance with Machinery Directives, Directive 2014/35/EU, Directive 98/79/CE, Regulation 2017-746.
• To prepare DOC (Declaration of Conformity) for self CE & compilation of technical file.
• To support in preparation of Risk Management File & Device Master Records in compliance with 21 CFR 820 & ISO 13485.