Ellecom GmbH
Booth number: G55
ellecom.de
About us
ELLECOM Group with subsidiaries in Switzerland, Germany, India and China 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 for Conformity Assessment for Medical Devices
Representative Services (EU-Authorized Representative and Swiss Authorized Representative)
Support in implementing Quality Management Systems ISO 9001 and ISO 13485
Support in implementing Information Management System ISO 27001
Audits, Trainings and Compliance
Our vision is to provide assuredly effective and efficient solutions and products for furthering our dream of a united community where everyone is healthy and has an opportunity to succeed.
Ellecom's team is knowledgeable, goal-oriented, and committed to quality and cooperation.
Address
Hauptstraße 12
79588 Efringen-Kirchen
Germany
E-mail: info@ellecom.de
Phone: +49 7628 8008407
Internet: ellecom.de
Ellecom Swiss AG -Kurzelängeweg 12
4123 Allschwil
Switzerland
E-mail: info@ellecom.ch
Phone: +41 766 800148
Internet: ellecom.ch/
Beijing Ellecom Technology Co., Ltd. - Room 1201, Unit 2, 11th Floor, Building 1, Courtyard 3, Changtong Road
000 Chaoyang District Beijing
China
E-mail: info@ellecom.de
Phone: +49 176 70188902
Internet: ellecom.cn/
Ellecom SGI Pvt. Ltd. - Shree Lalita Building, 2nd Floor, Juhu Tara Road, Above SBI
400049 Mumbai
India
E-mail: info@ellecom.de
Phone: +49 176 70188902
Internet: ellecom.in/
Contact person:
Antje Tandetzky
European Regulatory Affairs Director
E-mail: antje.tandetzky@ellecom.de
Phone: +4915170839375
Products & Services
>>Regulatory Affairs
Registration in 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 MDSAP, China NMPA and India ICMR Market Authorization Services.
>>Quality Standards
we assist with the implementation of ISO 9001, ISO 13485 and ISO 27001
>>Training
EU IVDR Compliance, EU MDR Compliance, Clinical Evaluation.
Clinical evaluation and performance evaluation for medical products and IVD
We provide clinical services and CRO services for manufacturers of medical products and IVD products.
In order to introduce a new medical product or IVD product, i.e to the European Union market or to Switzerland, it is necessary to show the product performance and safety through a clinical evaluation. We perform the medical writing and when necessary, organize, plan and execute the relevant studies for you through our network of partner clinics and hospitals in different European locations.
Regulatory Services and Market Authorization
In order to sell medical products, lab equipment and IVD products in another country, it is necessary to register the product with EUDAMED and aquire the CE certificate according to EU-MDR or EU-IVDR.
To obtain these we advise to perform a gap analysis first. We also support you with the function of PRRC, person responsible for regulatory compliance. Our regulatory strategy consulting will guide you and provide orientation on all topics related to market authorization.
Technical Documentation
In order to comply with the rules and regulations of the competent authorities of a new target market, it is necessary to check and update your technical documentation.
Shall you need Technical File Support our team of experts are here to assist you.
We guide you to obtain a complete Post Market Surveillance System and support in compilation of your Risk Management File, Usability Engineering File and other necessary documents.
We support you to fulfill the complete Labelling Compliance, too.
