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.
Registration with EUDAMED,
EU-IVDR and CE registration,
EU-MDR and CE registration,
Regulatory Strategy Consulting
clinical evaluation (MDR),
performance evaluation (IVDR),
Post Market Surveillance System,
Technical File Support,
i.e. EU-Rep Services and Swiss-Rep Services as well as USA FDA and China NMPA and India ICMR Market Access Services.
we help with implementation of seven different ISO standards.
EU IVDR Compliance, EU MDR Compliance, Clinical Evaluation.
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 accuracy through a clinical performance study. We organize, plan and execute these studies for you through our network of partner clinics and laboratories.
In order to sell medical products, lab equipment and IVD products in another country, it is necessary to register the product with EUDAMED, aquire the EU-IVDR and CE registration or alternatively the EU-MDR and CE registration. 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 access.
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 you 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.