Horizon 2020 Regulatory Consultant
Since 2014, Obelis Group has successfully participated in the Horizon 2020 Research Program. Obelis intends to continue this commitment and is, therefore, intensively involved in the discussion towards new highly innovative projects.
Obelis expertise is focused on health technologies, including medical devices (MD), cosmetics, and advanced therapy medicinal products (ATMP).
Furthermore, Obelis is answering the societal challenge Secure Societies - Protecting freedom and security of Europe and its citizens, providing ethics and data protection services.
Obelis, regulatory partner in H2020 projects, is proud to present its Regulatory Services in the largest European project for Research and Innovation run by the EU Commission – Horizon 2020.
- Management of regulatory issues impacting the project compliance,
- Expert in the security field involving ethical and societal aspects,
- Review and compile all documentation needed in order to assure a compliant prototype product,
- Identify regulatory requirements, standards and specifications,
- Assist all partners to properly explain, document, justify and validate all analytical tools, experimental steps and methods used,
- Contribute to the knowledge of all partners by maintaining an ongoing and close reference to current and future legislation and regulation.
Together with all partners, Obelis will ensure regulatory compliance of the project and its results towards relevant target groups. In addition, Obelis will support all partners in their activities and in questions concerning EU Regulations and compliance throughout the project.
H2020 Regulatory Services Include:
- Consultation on applicable regulations & classification,
- Identification of EU Harmonized Standards,
- Conformity Assessment routes & Notified Body selection,
- Technical documentation review,
- Product Notification/Registration to National Authorities,
- Ethics & Societal advisory services,
- GDPR & cyber-security compliance,
- Clinical testing &evaluation.
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