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FDA Quality System Regulation Compliance Audits and Gap Analyses

We assess the current state of FDA Medical Device Compliance of your manufacturing and established Quality System with respect to the Federal Regulations as follows:

  • 21 CFR Part 820 - Quality System Regulation;
  • 21 CFR 803 - Medical Device Reporting;
  • 21 CFR 806 - Medical Device Report of Corrections and Removals; and
  • 21 CFR 11 - Electronic Records and Electronic Signatures

We can provide recommendations related to improving the health of the established Quality System in order to achieve full FDA Compliance. We also audit third party facilities including Due Diligence audits, vendor qualification, supplier audits, and contract manufacturer cGMP and Quality System audits including all aspects of mock FDA inspections.


Quality System Development/Continuous Improvement

We can perform a wide range of services including a GAP analysis/Mock FDA Medical Device Regulatory Inspection of the existing Quality System, reviewing and recommending enhancements to your firm's organizational structure, QSR (Quality System Regulation) SOP development, and training. Additionally, we can assist start-up and medical device facilities in the infancy stages with a complete development of an FDA compliant and manageable Quality System.


FDA Inspections and Warning Letters

We can guide your firm through the systematic process of responding adequately to an FDA-483 (Inspectional Observations) or a Warning Letter situation. Many times, a well written FDA-483 and/or Warning Letter response can circumvent further regulatory action being taken by FDA. We are capable in aiding with all aspects of an FDA establishment inspection which include Pre-Inspectional preparedness to on-site FDA Inspectional support (front and back room assistance) in order to ensure that you are completely prepared for an FDA inspection. We can also be present for your actual FDA inspection in order to assist in a seamless interpretation of the direction of FDA Investigators during inspection.


Medical Device Reportable Adverse Events (MDRs) and Product Recalls

We provide assistance with respect to your FDA Regulatory record keeping requirements for MDR (Medical Device Reporting) systems. Additionally, we provide advice on necessary steps associated with medical device Product Recalls, Corrections and Removals, Stock Recoveries, and market Withdrawals.


Document Controls

We write and help you implement compliant cGMP (Quality System Regulation) required procedures including Work Instructions, etc. We will assist in writing required procedures associated within the FDA Quality Systems as follows:

  1. Management Control Programs, systems, and procedures
    • Internal Audit program
    • Management Reviews
    • Training matrix and expectations
  2. Design Control systems including all aspects of the expectations for
    • Design Plan
    • Design Inputs and Outputs
    • Design Verification and Validation
    • Design Reviews
    • Design Transfer
    • Design Changes
    • Design History Files (DHFs)
  3. CAPA Programs and procedures
    • Compliant handling including MDR handling
    • Nonconformance material handling (NCR or NCMRs)
    • CAPA and root cause investigation procedures
  4. Production and Process systems
    • Device Master Record (DMR)
    • Device History Records (DHR)
    • Process Validation

Copyright © 2021 Lori A. Carr / All rights reserved.