We provides advisory support to manufacturers on obtaining a certificate (CE mark) for medical devices. Legal consultants of our team have in-depth knowledge of MDR and experience in this kind of activity within the framework of European projects in the field of health care.
Cooperation includes a pre-assessment and based on its results, the determination of successive steps on the way to obtaining a CE mark. In addition, we can support companies in their relations with notified bodies, which are in most cases authorized to issue certificates.
We believe that ethics is not an afterthought, but a lens through which to view the entire journey of creating innovative solutions. That’s why we offer our expertise as External Ethics Advisors, supporting projects and organizations in managing ethics boards, reviewing project outputs, and assessing ethical and legal compliance—always with careful attention to the specific context.
We work with a range of clients and partners and have built a strong reputation in this field, recognized by the European Commission. Our approach is authoritative yet approachable, technically sound yet rooted in dialogue.
We use interactive workshops, guidelines, informational materials, and practical tools (such as helpdesks and tailored templates) not just as supports, but as core elements of our advisory and evaluation process. These tools help raise awareness, foster discussion, and build a shared, robust ethical approach with our partners and clients.
We intervene both during the development phase (to ensure the project is carried out in line with ethical principles and applicable regulations) and in the evaluation of final outputs (to verify their consistency with those same principles). We operate as internal consultants within consortia and project teams, as well as external experts and independent evaluators.
What sets us apart is the ongoing, direct dialogue we maintain with those we work with: we tailor our analyses, recommendations, and tools to the real needs of each project. We work side by side with clients and partners, with a critical but constructive perspective, to support them through every stage of their innovation journey.
We use our expertise in managing complex and international projects for the success of time sensitive projects with high impact in our clients’ organisations. We support our customers’ business objectives with responsibility to implement challenging projects which are ethically and legally compliant. Through our experience in many successful projects and our team members’ certifications (PMP, ITIL, PRINCE2, SCRUM), we apply program, project and service management best practices, agile methodologies and management skills. Clients can be assured that we are trustable and agile in taking care of their objectives pro-actively and with a profound professionalism. We also have the expertise to mentor our clients personnel through the process of adopting a more structured approach to an ethical management of their projects, helping them to move in the right direction to deliver successful and ethically compliant projects.