Ellecom GmbH
Booth number: 1M101
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
Kurzelängeweg 12
4123 Allschwil
Switzerland
E-mail: info@ellecom.ch
Phone: +41 766 800148
Internet: ellecom.ch/
Room 1201, Unit 2, 11th Floor, Building 1, Courtyard 3, Changtong Road
Chaoyang District
100024 Beijing
China
E-mail: info@ellecom.de
Phone: +86 183 10482513
Internet: ellecom.cn/
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:
Products & Services
>>Regulatory Affairs
- Regulatory Strategy Consulting
- Gap Analysis
- PRRC
- Identification of relevant standards
- Product Verification and Validation
- Compilation of Technical File
- MDSAP, China NMPA and India ICMR Market Authorization Services
>>Technical documentation
- Technical File Support and Guidance
- Post Market Surveillance System (Post-Market Surveillance Plan and Report, PSUR and PMCF)
- Risk Management Documentation
- Labelling Compliance
- ....
>>Clinical Affairs
- CRO services
- Clinical Evaluation/ Performance Evaluation Consultation
- Clinical Evaluation Plan and Report Writing
- Medical Writing
- Scientific Literature Review
- Clinical Study Design
>>Representative Services,
i.e. EU-Representative Services and Swiss-Representative Services
>>Quality Standards
we assist with the implementation of ISO 9001, ISO 13485 and ISO 27001
>>Training
Regulatary Affairs Trainings:
· Training Course: Person Responsible for Regulatory Compliance
· Training Course: Introduction to Unique Device Identification (UDI)
· Training Course: Implementation of the Medical Device Regulation (EU MDR 2017/745) for CE marking
· Training Course: Implementation of the In Vitro Diagnostic Device Regulation (EU IVDR 2017/746) for CE marking
· Training Course: Post Market Surveillance and Vigilance under the Medical Device Regulation (MDR) and In Vitro Diagnostic Device Regulation (IVDR)
· Training Course: Risk Management under the Medical Device Regulation (MDR) and In Vitro Diagnostic Device Regulation (IVDR)
Clinical Affairs Trainings:
· Training Course: Clinical Evaluation under the Medical Device Regulation (MDR)
· Training Course: Performance Evaluation under the In Vitro Diagnostic Device Regulation (IVDR)
Quality Management and IT Security Trainings:
· Training Course: Quality Management System ISO 13485:2016
· Training Course: Internal Auditor for ISO 13485:2016
· Training Course: Information Security Management System ISO 27001:2022
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.
