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 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.