Get access to the experts and project support you need to plan and execute department, site, or company-wide activities necessary to meet the European Union (EU) Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) requirements.
The FDA Group's EU MDR and IVDR team has helped many medical device and diagnostic companies—of all sizes—understand these regulations front to back and implement an efficient, comprehensive, and demonstrable approach to compliance.
Whether you need full-service support to develop and execute a compliant regulatory strategy or simply need to augment your internal resources or access additional expertise to manage specific complexities, The FDA Group will deliver the skills and experience you need, when and where you need it.
Get access to expert consultants as well as contingent or direct hire candidate search and placement services. We specialize in the entire range of the resourcing process, giving you a breadth of expertise that has become increasingly hard to find in the life science industry.
Put your projects in the hands of qualified third-party experts. Project-based consulting engagements are executed by an individual or team of specialized resources. Our dedicated project management team works closely with your leadership team to establish and track project milestones, schedule activities, guide resources, and report on success.
Get contracted full-time consultant (FTC) staffing support and functional outsourcing for specified or open-ended engagement durations—a flexible, convenient alternative to traditional hiring. Fill staffing assignments, bridge gaps, and fill interim and even long-term roles. Contracted resources can work on-site or off-site as a functional extension of your team.
Our resources can be utilized to meet the wide range of regulatory requirements, as well as to support staffing assignments, lead and manage related activities, bridge staffing gaps, and provide long-term or interim leadership.
Please contact us to learn more about fulfilling specific EU MDR and/or IVDR needs. We help clients secure a wide variety of life science resources for both contracted and direct hire engagements with the perfect combination of qualifications, experience, and motivation for succeeding in challenging and demanding projects.