FDA Inspection Readiness with confinis

Navigating U.S. Regulatory Requirements

For medical devices and combination products sold or intended to be sold in the U.S., adherence to specific regulatory standards is crucial. Your quality management system (QMS) must comply with 21 CFR Part 820 (Quality System Regulation) for medical devices, and for combination products, adherence to 21 CFR Part 4 is also required. At confinis, we ensure that your QMS aligns with these stringent American regulations, preparing your business for successful market entry and operations.

Mock Inspections: Your Pathway to Compliance

To verify compliance and prepare for actual regulatory scrutiny, confinis offers mock inspections in the form of internal audits. These simulated FDA inspections are conducted using the Quality System Inspection Technique (QSIT) to closely mimic a real FDA inspection. Our team of experts, including accredited third-party inspectors and former FDA inspectors, conducts these inspections rigorously.

Benefits of Mock Inspections:

  • Uncover Shortcomings

    Our detailed audit reports identify potential gaps and non-compliance in your current systems.

  • Process Improvement

    Findings from the mock inspections serve as a foundation for necessary corrections, allowing for the continuous enhancement of your QMS.

  • Reduced Inspection Anxiety

    With thorough preparation and corrective actions in place, you can approach the actual FDA inspection with confidence and calm.

Why Prepare with confinis?

Preparing for an FDA inspection with confinis not only ensures compliance but also equips your organization with the insights and tools to maintain and improve your quality standards. Mock inspections and subsequent process optimizations are essential for avoiding potential regulatory pitfalls and ensuring uninterrupted access to the U.S. market.

Ensure Your Success

Choose confinis for comprehensive support and expert guidance through your FDA inspection process. Our approach is designed to keep your operations compliant and efficient, giving you peace of mind as you navigate the complexities of regulatory approvals.