Ellecom GmbH

Booth number 2M-06

www.ellecom.de

Ellecom - Connected.Committed to Community. We offer regulatory, clinical and representative services as well as trainings for manufacturers of medical devices and IVD.

About us

We provide regulatory services to manufacturers of medical products, specifically In Vitro Diagnostics. Due to the high regulatory demand created by the European authorities through the implementation of new Medical device regulation (MDR) and In-vitro Diagnostic Device regulation (IVDR) manufacturers face a complex endeavour if they want to register their products.

We support them along the whole process of the market entry and offer all services to provide conformity with MDR and IVDR guidelines. We organize clinical evaluations or studies in European labs for our customer's products, help in creating the whole technical documentation, advise on how to fulfil labelling compliance, register their products with the different health authorities in all European countries, help them in obtaining the CE certificate and offer implementation of seven different ISO standards in their company.

Address
Ellecom GmbH
Friedrich-Ebert-Anlage 49
60308 Frankfurt am Main
Germany

Phone: +49 69 509565845
Internet: www.ellecom.de

Contact person

Ms Antje Tandetzky
Sales Director
Phone: +49151 70839375
Mr Hu Bo
Country Manager China
Phone: +49 151 51137732
Mr Rohit Zutshi
Managing Director
Phone: +49 176 70188902

Products and Services

  • EC Representative Services
  • CE according to (EU) 2017/745 MDR and (EU) 2017/746 IVDR
  • UDI Unique Device Identification - strategy consultation 
  • Post Market Surveillance System for MDR and IVDR
  • EU Registration with EUDAMED and the Competent Authorities of the EU member states
  • Regulatory Training for MDR and IVDR
  • Technical File Support for MDR and IVDR
  • Clinical Evaluation for MDR
  • Performance Evaluation for IVDR
  • Labelling Compliance
  • Implementation of ISO Standards 9001, 13485, 14971, 14001, 27001, 20416, 20417
  • Swiss Representative Services
  • Registration of devices with Competent Authorities of Switzerland
  • Labelling Compliance and Post Market Process Documentation for Switzerland
  • Distributor Services in India
  • Import Permission and Manufacturing Licence from CDSCO for India
  • Registration of devices with Competent Authorities of India
  • Certificate of Free Sales - Documentation and Submission for EU, Switzerland, India, Middle Eastern and Southeast Asian countries

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