Responding to New Regulatory Requirements in In-Vitro Diagnostics

The chief of staff for the quality organization of an F200 life science company needed to establish and implement a compliant workstream related to the specific requirements of current in-vitro diagnostics regulations (IVDR) and the development of IVDR capabilities. Given the recent changes to the regulations, the organization lacked the necessary internal expertise on the matter. Given the complexity and importance of the project, they felt execution-oriented consultant support was needed.

Business Talent Group (BTG) presented and deployed an IVDR expert paired with a former Bain consultant project manager, both with extensive pharma experience. The consultants developed key operational processes and implemented standardized workflows based on industry best practices and applicability to specific business requirements for business continuity. Project deliverables included a current gap assessment, a comprehensive quality plan, training, coaching, and mentoring to the organization on IVDR language, and a communication strategy to deliver throughout the organization on changes and impacted functional areas.