Challenge: A major European Notified Body needed to quickly upskill their assessment team on IVDR requirements and performance evaluation processes to handle the influx of new submissions.

Solution: MDx delivered a specialized training program for NB assessors that included:

• In-depth workshops on performance evaluation review
• Case-based learning with real-world technical documentation examples
• Assessment checklists and decision-making frameworks
• Ongoing support and refresher sessions as interpretations evolved

Result:  The Notified Body successfully trained 15 assessors with transformative efficiency gains. Our structured program reduced the assessor qualification journey from 18 months to just 6 months-a 66% reduction in onboarding time for new technical reviewers. The assessment team reported 40% faster review times after training completion, significantly increasing throughput capacity while maintaining rigorous compliance standards. Notified Body leadership reported substantial improvements in both operational efficiency and manufacturer satisfaction through more consistent, transparent, and timely evaluation.