艾利康科

Hall: hall1

Stand no: 1M101

ELLECOM Group with subsidiaries in Switzerland, Germany, China and India assists manufacturers in gaining market authorization around the world through successful device certification. Our services include: -Regulatory Affairs, especially Technical File Compilation for EU-MDR and EU-IVDR -Preparation of MDSAP Documentation -Clinical Affairs, including the set-up and execution of Clinical Evaluation Studies -EU-Authorized Representative and Swiss Authorized Representative -Support in implementing Quality Management Systems ISO 9001 and ISO 13485 and ISMS ISO 27001 -Audits, Trainings and Compliance Ellecom's team is knowledgeable, goal-oriented, and committed to quality and cooperation.

Products and Service Categories

Consultants - Consultants - Asia: marketplace/regulations

Consultants - Consultants - Europe: marketplace/regulations

Consultants - Consultants - Good manufacturing practices/compliance

Consultants - Consultants - Quality management