ELLECOM®

medical devices

About

ELLECOM works passionately to solve challenges in the areas of regulatory affairs, clinical affairs and quality management for manufacturers of medical devices and IVD. ELLECOM Group with subsidiaries in Switzerland, Germany, India and China assists manufacturers in gaining market access around the world through successful device certification. Our dedicated and results-driven teams combine their broad range of knowledge and expertise in medical devices and offer full regulatory support. Our mission is to explore opportunities and resources to improve the quality of life with our products and solutions keeping in mind safety and success. Our vision is to provide assuredly effective and efficient solutions and products for furthering our dream of a united community where everyone is healthy and has an opportunity to succeed.

Technologies

Outlook Microsoft Office 365 Mobile Friendly Apache Bootstrap Framework

Keywords

technical documentation validation medical device certification ec representative service regulatory affairs clinical evaluation for medical devices ivdr post market surveillance system mdr medical technology authorized representative services for the eu & switzerland clinical affairs compliance eu regulation clinical validation post market surveillance ce regulation 2017 verification quality management audits trainings udi performance evaluation ce regulation risk management performance evaluation for ivd medical equipment manufacturing b2b regulatory expertise iso 9001

Location

Efringen-Kirchen, Baden-Wuerttemberg, Germany, 79588

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