Ellecom GmbH
Booth number: HALL 6A -A7-20
www.ellecom.de
About us
Ellecom - Regulatory and Compliance Solutions for Medical Devices and In Vitro Diagnostics
Ellecom has expertise and competence in meeting demanding regulatory requirements in an international context. We are a leading partner in the execution and tracking of regulatory, clinical and technical documentation. This enables us to provide maximum efficiency in product registration.
The changing regulatory framework created by the implementation of the EU Medical Devices Regulation (2017/745) and the EU In Vitro Medical Devices Regulation (2017/746) is impacting how medical devices and IVDs are reclassified and, where applicable, upscaled.
Companies with knowledge and experience of regulatory issues will find it easier to ensure a smooth transition.
Over the years, Ellecom has established sustainable business relationships with various competent authorities, notified bodies, clinical laboratories and think tanks.
Address
Friedrich-Ebert-Anlage 49
60308 Frankfurt am Main
Germany
Phone: +49 176 70188902
Contact person:
Rohit Zutshi
Managing Director
E-mail: rohit.zutshi@ellecom.de
Phone: +49 176 70188902
Antje Tandetzky
Sales Director
E-mail: antje.tandetzky@ellecom.de
Phone: +49 151 70839375
Products & Services
>>Regulatory Affairs
Registration with EUDAMED,
EU-IVDR and CE registration,
EU-MDR and CE registration,
Gap Analysis,
PRRC,
Regulatory Strategy Consulting
>>Clinical affairs
CRO services,
clinical evaluation (MDR),
performance evaluation (IVDR),
>Technical documentation
Post Market Surveillance System,
Technical File Support,
Labelling Compliance
>>Representative Services,
i.e. EU-Rep Services and Swiss-Rep Services as well as USA FDA and China NMPA and India ICMR Market Access Services.
>>Quality Standards
we help with implementation of seven different ISO standards.
>>Training
EU IVDR Compliance, EU MDR Compliance, Clinical Evaluation.
Clinical evaluation and performance evaluation for medical products and IVD
Regulatory Services and Market Access
Technical Documentation
We guide you to obtain a complete Post Market Surveillance System.
Shall you need Technical File Support our team of experts are here to assist you.
We support you to fulfull the complete Labelling Compliance, too.