Don’t Risk Compliance with EUDAMED
Companies in the field of Medical Technologies, which is one of the fastest developing sectors in the USA and the EU, should have a good strategy and management model in order to develop their product range and to open up to promising geographies. At the same time, these companies must comply with the necessary regulations. The high-quality support in terms of compliance with these regulations is provided by JURCOM. The EUDAMED Directive, the European Union’s directive on medical devices, is one of JURCOM’s areas of expertise. JURCOM provides regulatory compliance projects, risk assessments, audit services and software concerning MedTech.
Consultancy Services
Regulatory Assessment
We can help you determine your obligations under the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) with respect to EUDAMED, based on the classification, type, and intended use of your medical devices.
Training and support
We can provide you with training and support to help you understand the EUDAMED requirements, use the EUDAMED system, and maintain compliance over time.
Gap Analysis
We can perform a detailed analysis of your current processes, systems, and data to identify any gaps or deficiencies that may prevent you from complying with the EUDAMED requirements.
Implementation Planning
We can help you develop a customized implementation plan that takes into account your specific needs, resources, and timelines, as well as the evolving regulatory landscape.
