Ellecom GmbH
Booth number: 13F21
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 according to the EU-MDR and EU-IVDR regulations. 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 Diagnostic Devices Regulation (2017/746) is impacting how medical devices and IVDs are (re)classified and is increasing the expenditures on documentation.
Companies with knowledge and experience of regulatory challenges 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
Hauptstr. 12
79588 Efringen-Kirchen
Germany
Phone: +49 7628 8008407
Room 1201, Unit 2, 11th Floor, Building 1, Courtyard 3, Changtong Road, Chaoyang District
Bejing
P. R. China
E-mail: Bo.hu@ellecom.cn
Phone: +86 183 10482513
Internet: https://ellecom.cn/
Contact person:
Rohit Zutshi
Managing Director
E-mail: rohit.zutshi@ellecom.de
Phone: +49 176 70188902
Hu Bo
Regulatory Affairs Director China
E-mail: Bo.hu@ellecom.cn
Phone: +86 183 10482513
Antje Tandetzky
European Regulatory Affairs Director
E-mail: antje.tandetzky@ellecom.de
Phone: +49 151 70839375
Products & Services
→ Regulatory Affairs
- Regulatory Strategy Consulting
- Gap Analysis
- Registration in EUDAMED
- Technical File Compilation for CE registration according to EU- MDR and EU-IVDR
- Service as an external PRRC
→ Clinical Affairs
- CRO services, e.g. Clinical Data and Study Management, Medical Writing
- Set-Up and Execution of Clinical Evaluations for Medical Devices and Performance Evaluations for IVD
→ Technical Documentation Support, e.g. Post Market Surveillance
System Set-Up, Risk Management File Support
→ Representative Services
- i.e. EU-Rep Services and Swiss-Rep Services as well as China NMPA
and India ICMR Market Access Services.
→ Quality Management Standards
- Implementation different ISO standards, e.g. ISO 13485:2016 and ISO 9001:2015
→ Training Courses
- Topics: EU IVDR Compliance, EU MDR Compliance, PRRC, UDI, PMS, Risk Management, Clinical Management, Quality
Management System ISO 13485:2016
Regulatory Services
Implementation of Quality Management Standards
We are your competent partner and guide you through the process of document compilation and support you in wholly setting up these standards sustainably.
Representative Services
Ellecom can be your Authorised Representative in the European Union and in Switzerland and guide you along the process of product registration. Reach out to our team to learn more about our services.
