Archives: Case studies

Challenge: CAP-accredited lab needed IVDR Article 6 compliance for EU patient testing.

Solution:

• Technical documentation development alignment with Annex I 
• Development of product Labelling and instructions for use 
• Implementation of IVDR compliance PMS systems
• UDI implementation
• Notified Body selection and followed through CE certification

Result:
Continued EU market access with 100% regulatory compliance.

Challenge: Major EU cancer center needed to maintain NGS-based LDTs under IVDR while continuing pharma trial partnerships.

Solution:

• Implemented Article 5(5) justification framework
• Developed GSPRs & technical documentation under IVDR 
• Integrated ISO 15189 with 13485 and IVDR-compliant PMS

Result:
All tests maintained with zero service interruption. The laboratory was allowed to continue offering local tests in clinical trials.

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.

Challenge: A leading medical device manufacturer with 30+ legacy products needed to prepare their regulatory affairs, quality, and R&D teams for MDR transition within a compressed timeline.

Solution: MDx developed a comprehensive 12-week hybrid training program including:

• Executive briefings for leadership
• Technical workshops for subject matter experts
• Role-specific training modules for different departments
• Hands-on documentation workshops using the client’s actual products
• Virtual coaching sessions for distributed teams

Result: 65 employees across 3 countries successfully trained, resulting in a structured transition strategy. The company established an internal “MDR Center of Excellence” using our materials and train-the-trainer approach.

Challenge: A diagnostic company developing a novel lateral flow assay for home use needed comprehensive usability engineering to satisfy both FDA and IVDR requirements for lay users.

Solution: MDx implemented a complete usability engineering program including:

• User research with target patient populations
• Iterative formative testing across three design cycles
• Comprehensive instructions for use validation & label comprehension studies
• Summative validation with 60 participants across three countries

Result: The client’s self-test IVD received both FDA clearance and IVDR certification with zero usability-related findings or deficiency letters.