October 2011 - Level 3 Inspection

Archive for October, 2011

FDA’s Five Year Plan: Doing More with Less

The FDA recently unveiled its Strategic Priorities 2011-2015.

How will the next five years’ goals and objectives affect you?

Everybody’s operating under a tighter budget these days.  “Lean government” has become a buzzword.  Even the politicians finally seem to have noticed lean processes that manufacturers have been studying and implementing for decades.

The FDA has noticed, too.

To serve the FDA’s objectives of efficiency, consistency and effectiveness, industry is being asked to revisit the way that processes are developed and documented — standardizing the enormous amounts of product data that manufacturers send in.  Ever more responsibility is shifting to the medical device industry to track data on its outsourced supplies.

With accurate and comprehensive computer-aided inspection (CAI) you can satisfy regulators by recording and documenting every surface data point and every extracted dimension for future reference — while cutting iterations, months, and millions of dollars from the process development schedule.

Visit www.level3inspection.com or call us today to learn more!

WARSAW, IN • STUART, FL
574.383.9145 • 561.775.7911
Copyright © 2011 Level 3 Inspection LLC, All rights reserved.

FDA’s Five Year Plan: Analytical Tools Initiative

The FDA recently unveiled its Strategic Priorities 2011-2015.
How will the next five years’ goals and objectives affect you?
The Analytical Tools Initiative (ATI) is the FDA’s program to study new analysis and informatics tools – such as computer aided inspection (CAI) – that are useful to the field investigator.  At ports of entry and at suppliers’ facilities, fast and comprehensive inspection assures higher standards of compliance.
Satisfy the field agents, reduce your supplier risk and increase your throughput at the same time with the world’s most accurate and comprehensive CAI.

Visit www.level3inspection.com or call us today to learn more!

WARSAW, IN • STUART, FL
574.383.9145 • 561.775.7911
Copyright © 2011 Level 3 Inspection LLC, All rights reserved.

FDA’s Five Year Plan: The Global Supply Chain

The FDA recently unveiled its Strategic Priorities 2011-2015.
How will the next five years’ goals and objectives affect you?
As the orthopaedic supply chain globalizes, assuring quality parts is becoming more and more the responsibility of the OEM’s.  In a competitive and high-stakes industry, in which tolerances can be as minute as a few ten-thousandths of an inch, it’s critical that supply-chain parts be faithful to model and print – and more and more the FDA is leaving that responsibility in the hands of manufacturers.

Supplier rating gets more and more complicated as bids come in from vendors across several continents.  The FDA is forcing the industry to identify and control supplier risk. Trial-and-error verification is a prohibitively expensive proposition, but a failure of compliance would be catastrophic.

Accurate and comprehensive computer-aided inspection (CAI) can restore your confidence in the stream of supply chain parts, without breaking the bank and wasting valuable time.

Visit www.level3inspection.com or call us today to learn more!

WARSAW, IN • STUART, FL
574.383.9145 • 561.775.7911
Copyright © 2011 Level 3 Inspection LLC, All rights reserved.

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