• 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

When Quality Counts

Whether your application requires a pressure-sensitive label or an FDA-compliant disposable medical device, one thing in every project is true: a commitment to quality makes a difference in the end product.

It’s an easy sentence to type but a difficult concept to achieve. Here at ATL, we live that commitment every single day by consistently taking a Six Sigma approach in accordance with a number of standards and regulations, including ISO-13485, MDD 93/42/EEC and FDA cGMP.

These protocols, which involve a variety of elements, always begin with the same steps:

  1. Formulate product development by identifying customer needs from a variety of perspectives, including:
    • Stated customer requirements (the intended use of the product)
    • The Six-Sigma approach of DMAIC - Define, Measure, Analyze, Improve, Control
    • APQP (Advanced Product Quality Planning)
  2. Define and Implement process development from the customer's design goals by determining:
    • Necessary materials
    • Process flow
    • Timeline for completion
    • ATL roles and responsibilities
    • Feasibilities of the proposed product as ranked by manufacturability (cost effectiveness)
    • Feasibilities of the proposed product as ranked by potential product hazards to the end user (FMEA or ISO-14971 Risk Analysis)
  3. Measure, Analyze, Improve, and Controlthe manufacturing process by:
    • Understanding the critical to quality characteristics (CTQ’s) required by the client
    • Determining process stability
    • Determining process capability
    • Determining packaging standards
  4. Develop the client's product control plan or FDA cGMP Performance Qualification (PQ), which covers:
    • Product
    • Process
    • Operations
    • Machines
    • Characteristics class
    • Specification tolerances
    • Measurement technique
    • Cpk determination
    • Sample size
    • Sample frequency
    • Control method
    • Reaction plan

The process is time consuming and detail oriented but always attempts to achieve this final goal: the best product for the client made the best way with the best materials.

Click here to view a PowerPoint providing more details on our system validation protocolsand, when quality is paramount, make sure to contact ATL for assistance with your disposable medical device or pressure-sensitive label.

Process Capability for Disposable Medical Devices
Recap of BIOMEDevice/ Design and Manufacturing Sho...

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