Ellecom GmbH

The ELLECOM Group, with offices in Switzerland, Germany, India and China, supports medical device manufacturers in successfully obtaining MDR and IVDR certification to ensure EU-wide market access.

• Our services include, among others.:
• Regulatory Affairs, in particular the compilation of technical documentation in accordance with EU MDR and EU IVDR
• Drafting of MDSAP documentation
• Clinical Affairs, including the planning and implementation of clinical evaluation studies for the conformity assessment of medical devices
• EU Authorized Representative and Swiss Authorized Representative
• Support for the implementation of the ISO 9001 and ISO 13485 quality management systems
• Support for the implementation of the ISO 27001 information management system
• Audits, training and compliance

• Regulatory affairs for medical devices and IVDs
• QMS and ISMS for medical device manufacturers"