- FDA regulations are constantly changing, and the medical device industry is advancing quickly.
- Gaining market clearance can seem like targeting a shifting goal because of the evolving requirements.
- Changes in international regulations, such as the EU Medical Device Regulation (MDR), may bring unexpected compliance challenges.
- Global Regulatory MedDev is renowned for helping medical device manufacturers overcome intricate regulatory hurdles, including remediation processes.
- Our seasoned experts are adept at crafting responses to regulatory measures such as 483 Observations, Warning Letters, Untitled Letters, and Consent Decrees.
- Beyond initial reactions, Global Regulatory MedDev supports organizations in implementing action plans, cultivating a culture of enhanced compliance, and becoming more robust after regulatory scrutiny.

Global Regulatory MedDev provided services in the area of remediation, which included:
Quality Management Systems Gap Analysis:
- Conduct a thorough gap analysis to assess the scope, compliance readiness, and resource support within your QMS.
- Identify and characterize system gaps to understand their nature and impact.
Root Cause Identification:
- Based on the nature of the problem that prompted the gap, consider two practical ways to eliminate it:
Resource Augmentation:
- Get more resources (e.g., hire contracted specialists) if needed.
Process Change: -
To address the gap, change your approach (e.g., adopt expedited procedures).
- Ideally, both approaches should be combined for comprehensive remediation.
Implement Solutions:
- Utilize the information uncovered during gap identification.
- Consider what’s needed to implement each solution from the outset.
- Some gaps may require external resourcing (e.g., contracted experts) to address larger issues or complex fixes.
Timeline Considerations:
- Document known dates and timelines for the project plan.
- Prioritize actions based on potential impact on other projects or deadlines.
- External resourcing partners can help protect project schedules.
Design History File (DHF) remediation:
The DHF includes various modules and important components:
- Design Input/Output (DI/DO) - Design Verification (DV)
- Risk Management Files (RMF): - Documentation related to risk assessment.
- Design and Development (D&D)
- Evaluating manufacturing processes.
- Device Master Record (DMR)
Technical documentation remediation:
- General Safety and Performance Requirements (GSPR)
- Clinical Evaluation Plan (CEP) and Report (CER)
- Transition from MDD/AIMDD to EU MDR/IVDR
Manufacturing Support:
- Validation and Re-validation of processes and Equipment Qualifications
- Manufacturing processes documentation
Software as Medical Device (SaMD):
- SaMD Risk Categorization
- SaMD’s clinical performance
- Implement a post-market monitoring program
- Aligning software with regulatory requirements
- CyberSecurity
Regulatory Actions:
- Complaints assessments Investigations
- CAPA process
- Supplier quality management and agreements/contracts
- Notified Body nonconformities responses