The most significant challenge facing IVD manufacturers today is the simultaneous overhaul of major quality and regulatory frameworks worldwide, particularly the EU’s IVDR and the FDA’s shift to the QMSR (aligned with ISO 13485).
Internal resources lack the bandwidth and specialized expertise to execute these complex transitions under tight deadlines. This leaves companies struggling with:
Legacy Device Transition: Massive effort required to update the QMS and technical files for devices previously on the market.
Continuous Compliance: The need to shift from a one-time approval mindset to an ongoing Quality Lifecycle approach that demands continuous Post-Market Performance Follow-up (PMPF) and real-time risk integration.
Documentation Burden: Insufficient digital tools and personnel to manage the exponentially greater volume of required clinical evidence, leading to compliance gaps and audit failures.
If your Quality Management System isn’t proactively assessed, upgraded, and integrated with current global requirements, you face the very real risk of delayed market entry, expensive non-conformities, or product withdrawal. Partner with the MDC team to build out and strengthen your quality management system.
Audrey Skeen
Quality Systems Specialist
Setup
- QMS/eQMS strategy and implementation
- eQMS platform selection and validation
- Registrar and Notified Body selection
- QMS and FDA inspection training
Continuous Support
- QMS Management
- Internal Quality Audits (IQA)
- CAPA management and audit remediation
- Complaint management
- FDA QMSR gap assessments
- Certification support for ISO, MDSAP, EU MDR/IVDR audit preparation
- CLIA Lab QMS accreditation support
- FDA Inspection preparation and Inspection support
Vigilance and Remediation
- FDA 483 response and Warning Letter Response support and remediation
- Product recalls and withdrawals
- Adverse Event reporting for FDA MDR, and EU
- Post Market Surveillance
Core Solutions
WE ARE SPECIALISTS
CLINICAL SERVICES
REGULATORY SERVICES
With you from strategy through submission.
QUALITY SERVICES
Quality system planning, audit support and remediation.