• Medical
    THE RESPECTED SOLUTIONS PROVIDER IN
    THE FDA cGMP COMPLIANCE ARENA
  • Industrial
    UNBEATABLE QUALITY & RELIABLE SERVICE
    DELIVERED ON SCHEDULE
  • Direct Mail
    MEETING YOUR TIGHT TURNAROUNDS
    & STRICT MAIL DROP DATES
  • Product Identification
    QUALITY-MINDED, CUSTOMER-DRIVEN
    LABEL SOLUTIONS

Donald J. Dobert (Don), President and COO of ATL

Insights into the custom label & disposable medical device markets from Don Dobert, ATL president & COO

Control Plans for Disposable Medical Devices

The customers of many disposable medical device manufacturers require that their vendors adhere to a quality management system that is demonstrably planned and complete.

To do so, manufacturers often find they must:

  • Complete quality assurance functions and inspections for critical characteristics on their disposable medical devices
  • Detail, in chronological order, all phases of their production processes
  • Provide proof of cGMP compliance (Current Good Manufacturing Practices) for FDA products, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)

Our article entitled “What is a Control Plan or FDA Performance Qualification (PQ)” strives to help you understand the methods and control points the FDA and/or customer auditors will be looking for.  An actual Control Plan/ Performance Qualification is included for your review.  Please click here to read the article.

Systems Validation Protocol Methods for Disposable...
Process FMEA for Disposable Medical Devices

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