A leading medical device manufacturer engaged ICON with conducting a regulatory assessment and remediation program to comply with IVDR. ICON was tasked with developing a remediation program encompassing a product portfolio spanning more than seven automated instruments and more than 500 analytes or assays.

ICON took a holistic approach and conducted a portfolio analysis. A working timeline was established to remediate and review all technical files for submission to NB for review. 

ICON’s Medical Device & Diagnostic Research team of experts provided cross-functional subject matter expertise on template development and training for best documentation practices, including: 

– Authoring Performance Evaluation Reports 

– Conducting literature searches including developing protocols such as search strategies, screening, data extraction and reporting 

– Authoring technical files, in addition to documenting assembly and submission 

The ICON and client teams met regularly to review project updates, discuss challenges and implement solutions, and review budget and forecasting.

ICON demonstrated consistency, transparency and accountability throughout the process by implementing a governance model to establish priorities and responsibility. This resulted in successful and timely completion of technical file assembly and delivery, meeting all initial pilot and full program requirements and deadlines enabling the client to submit for notified body review. ICON’s successful, strategic approach has led to additional projects within the client organisation.