This document provides information about ATL, a 55-year-old FDA registered medical device manufacturer and label printer. It details ATL's focus on quality through measures like six sigma training, ongoing validation, and passing 18 external audits. The document also outlines ATL's services like brand protection, serialization, engineering support, and medical product labeling and manufacturing. It promotes ATL's ability to ensure quality products and reduce clients' costs.

2. Who Is ATL? Label Printer and Converter Menomonee Falls, WI

3. Who Is ATL? 55 Year Old Company

4. Who Is ATL? FDA Registered Medical Device Manufacturer

5. Who Is ATL? cGMP Compliant to 21 CFR 210, 211, & 820

6. What makes ATL different? Quality What exactly is “Quality”? Quality means conformance to requirements.

7. How is this done? Through Quality Assurance

8. Quality Assurance at ATL Six Sigma Black Belt Experience

9. Quality Assurance at ATL Certified Security Personnel

10. Quality Assurance at ATL Ongoing Systems Validation Protocol

11. Quality Assurance at ATL Total Conformance: 2007 99.97% 2008 99.98% 2009 99.95%

12. Steps taken to ENSURE quality products…

13. Quality Management System A capable and controlled (written) manufacturing system.

14. Quality Management System Failure Modes & Effects Analysis (FMEA)

15. FMEA is done through Internal and External Audits…

16. Internal Audit Process – Sample Job Flow

17. External Audits at ATL ATL has successfully passed eighteen on-site ISO-9000 and cGMP compliance audits from pharmaceutical and medical companies since November 2000. Companies include: Novartis Bristol-Myers Squibb (BMS) Sanofi-Aventis Abbott Laboratories Pfizer Johnson & Johnson Eli Lilly GE Medical Schering-Plough

18. Standard Operating Procedures…

19. SOP Sample

20. Written Control Plans…

21. Written Control Plan Sample

22. ATL’s Available Services:

23. Brand Protection / Security

25. Mass Serialization

26. Custom Codes

27. 2D BarcodesPlus….

28. Brand Protection / Security Authentication/Tamper Indicating Covert Marking or Taggants in Ink or Varnish The PocketSureTM reading device uses proprietary algorithms configured by InkSure Technologies to detect the hidden code or image. Each code is unique.

30. Easily incorporated into any design.

31. Decoded with an optical lens, proprietary software, or iDetector Mobile Authentication Device. Example of printed layers Example of optical lens decoding hidden message

32. Supply Chain Management and Auditing

33. Loss Prevention Assistance

34. Medical

35. Medical Custom Die Cutting and Printing; Master Roll Distribution – Medical Tapes and Foams

36. Medical Island Placement

37. Medical Wound Care and Hydrogel Manufacturing

38. Medical Material Lamination

39. Medical Cold Sealing, Pouching and Packaging

42. Label Capabilities Multi-Panel Booklet Labels, 3-35 Pages

43. Label Capabilities Wrap-Around Construction for Small Cylinders

44. Other Label Capabilities Scratch Offs Cold Foil Printing Piggyback Constructions Peel Cards Product Identification Labels

45. What is it costing you not to use ATL?

46. ATL Medical www.atlco.com Mike O’Connell moconnell@atlco.com