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.

At JURCOM, we understand the challenges that medical device manufacturers face in complying with the European Union’s new regulatory framework for medical devices. One of the key components of this framework is EUDAMED, the European Databank on Medical Devices, which is designed to provide a centralized and harmonized system for collecting and sharing information on medical devices throughout their lifecycle.
Our EUDAMED consultancy services and technical solutions are designed to help you navigate the complexities of EUDAMED and ensure that you meet your regulatory obligations in a timely and efficient manner. Whether you are a manufacturer, authorized representative, importer, or distributor, we can provide you with the expertise and tools you need to comply with the EUDAMED requirements.
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.

Technical Solutions

Data privacy

We can help you ensure that your data is processed and stored in compliance with the EU General Data Protection Regulation (GDPR) and other applicable data protection laws and regulations.

Data migration

We can help you migrate your legacy data from your current system to the EUDAMED system, ensuring data integrity, accuracy, and completeness.

Data analytics

We can provide you with analytical tools and dashboards that enable you to monitor and analyze the data on your medical devices in real time, identify trends and patterns, and generate insights for decision-making.

System integration

We can help you integrate your existing quality management system (QMS) or product information management system (PIM) with the EUDAMED system, using industry-standard protocols and APIs.

Data management

We can help you collect, validate, and upload the required data on your medical devices to the EUDAMED system, using our proprietary software tools and templates.
Contact Us Today 

Contact us today to learn more about our EUDAMED compliance services.