John Gagliardi is a faculty member with AAMI, Washington, DC. He co-teaches ISO 13485, 21 CFR, Part 820,
Design Controls, and has developed a new course
on Document and Data Control. AAMI is the Association for the Advancement of Medical Instrumentation.
The auditing class was a huge success and continues to make
an impact at medium to large companies. Future webinars will
include Purchasing Controls, Change Management and
Management Responsibility.
John Gagliardi and MidWest Process Innovation will be actively involved with these education and quality-related activities in 2011:
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John is teaching a course addressing
the new GHTF guidance for purchasing controls. -
John successfully filed eight 510(k)s in 2010, and is working
with two companies on a PMA. -
MidWest Process Innovation, LLC will conduct over 45 audits concerned with compliance to ISO 13485:2003, ISO 17025 and 21 CFR,
Part 820 in 2011. -
John has recently developed new curricula for courses concerned
with labeling and label controls. These course
curricula are complete and dates are being scheduled for 3rd and 4th quarters of
2011. -
MidWest Process Innovation is assisting Chinese, Indian, and
Mexican customers with ISO 13485:2003. We had three successful ISO
certifications in 2010 and three more ISO certifications are
projected for end of 2nd quarter, 2011.
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MidWest Process Innovation is now a US Agent and Official
Correspondent to over 25 companies worldwide. -
John has been instrumental in helping medical-device companies
with FDA Inspections throughout 2011. -
John recently wrote articles concerning design controls,
handling FDA inspections, and
change management. Contact John
for a copy of each.
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Much of MidWest Process Innovation's business efforts have been
overseas this year (Europe, Mexico, China, India, Canada), with a
continued focus on start-ups with aspirations of becoming compliant with design
controls.
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A new workshop addressing design controls has been presented at the OMTEK conference this year.
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A new internal auditing class is currently under development.
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