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.
Ellecom is your partner to solve your regulatory and compliance challenges. Reach out to us for regulatory strategy consulting. We provide a thorough Gap analysis and support you in creating, compilating and revising your complete technical file for your medical product or in vitro diagnostic device.
You plan on introducing the ISO standards ISO 9001:2015, ISO 13485:2016 or the Information Management System Standard ISO 27001: 2022 in your organization?
We are your competent partner and guide you through the process of document compilation and support you in wholly setting up these standards sustainably.
If you plan on introducing your medical devices or in vitro diagnostic devices in the European Union or in Switzerland, you will need a local representative.
Ellecom can be your Authorised Representative in the European Union and in Switzerland and guide you along the process of product registration.
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