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One-Year Exemption from FDA Inspections Possible
Some medical device manufacturers qualify under ISO 13485
Congress Can Wait… But the FDA Won’t
The FDA’s new enforcement culture won’t compromise public safety
Savvy Compliance Strategy Can Improve GMP
The Circle of Compliance prevents the merry-go-round of audits and fixes.
Achieving the LIMS Promise
What application convergence means to the future of laboratory automation

On My Honor
Is the concept of honor simply too difficult to understand?

FDA Inspectional Observations Increase Focus on Qualifications, Personnel Training
Appropriate training will bring considerable business value to your organization.
Defining Quality: The FDA’s Position on Good Manufacturing Practices
More Stringent FDA Review Processes for Medical Devices on the Horizon
The FDA prepares to review and revise the 510(k) process.
Precise Pipetting Helps Set Standards for Molecular Diagnostics
MMQCI uses ARTEL PCS to strengthen liquid handling quality assurance
On-Demand Compliance Software Helps Small Medical Device Makers Compete
Subscription-based quality management and compliance software levels the playing field.
Electronic Medical Device Reporting Best Practices
Steps for a smooth transition from paper-based reporting
Good night and sweet dreams!
Accurate scanning of CAD files and injection molded prototype parts help launch new anti-snoring device.

New Protocols Will Test Effects of RFID Systems on Medical Devices
Georgia Tech Research Institute recently began developing testing protocols for RFID technology in the health care setting.
New Food Safety Policy Adds to Confusion
HR2749 and NAIS explained
ISO 13485: Creating a Globally Harmonized Quality System
An overview of the standard's requirements and use around the world.
Analyzing Data Saves Millions for County Tax Payers
Statisitical analysis was critical to Six Sigma team's success.
Can You Twitter Your Way to Performance Excellence?
The possibilities are out there.
Verifying the Effectiveness of Corrective Action
Verification isn't an act of suspicion; it’s a necessary part of problem solving.
Part Tracking Keeps Suppliers/Customers Happy
How do you manage 15,000 parts?
How Accreditation Could Have Prevented an Outbreak of SARS
Standards and accreditation can and do save lives.

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