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:
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.
