• 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

Process Capability for Disposable Medical Devices

Do you design, order, or have responsibility for quality assurance functions (inspections) for critical characteristics of disposable medical devices

Quality actually starts when the first concept of the product idea is postulated by the design engineering team.  The manufacturing of medical devices (made of medical foam or tape) is much different than manufacturing “rigid” items such as plastic components for a car.  This is because most medical materials have an elongation factor, so accurate and precise measurements usually demonstrate more variability. 

The article entitled “Process Capability/Medical Devices” strives to help you understand the common pitfalls in the main aspects of disposable medical device manufacturing (converting) from:

  1. The physical properties in the selection of materials
  2. Process inspection/controls
  3. The expression of critical characteristics into Cpk terms (capability)
  4. Accurately estimating your possible production failures and expressing this figure in defects per million.

 Click here to learn more about Process Capability for disposable medical devices.  

Risk Analysis for Disposable Medical Devices
When Quality Counts

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