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Regulatory and Quality
Systems Solutions
for the Medical Device Industry |
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Business-Friendly Results |
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A “business-friendly” approach can have dramatic results.
What can our business-friendly approach do for your company?
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 From
Two Warning Letters to No 483!
A small manufacturer of electronic device accessories implements a
business-friendly quality system after their second warning letter. Their next
inspection resulted in no observations!
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Better Complaint Handling, Easier Process!
A large IVD manufacturer implements a streamlined complaint handling process
that removes bureaucracy and shortens cycle time while improving
problem-solving ability, increasing customer satisfaction, and pleasing their
FDA inspector!
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 From
Overwhelmed to Mission Accomplished!
A small company finds out the hard way (warning letter) that they are an
FDA-regulated firm. Within 90 days, the company implements a quality system to
meet FDA commitments, and is now looking forward to a CE mark!
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Cleared!
Smart strategies help a company get a product through the 510(k)
process in time to meet a critical market window!
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 Skeptical
CEO is Converted!
A CEO clashes often with quality professionals, and views the quality system as
a "necessary evil". Business-friendly approach turns same CEO into a quality
advocate!
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Amica Solutions
2300 McDermott Road, #200-207, Plano, TX 75025
Phone: 972-849-5167
E-mail: koakes@amicasolutions.com |
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