John Gagliardi is now a faculty member with AAMI, Washington, DC. He co-teaches ISO 13485, 21 CFR, Part 820 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 and Change Management.

John Gagliardi and MidWest Process Innovation will be actively involved with these education and quality-related activities in 2008:

  • John is teaching an Advanced cGMP-QSR Course in January, June and November, 2008 (public course).

  • John successfully filed nine 510(k)s in 2008, and is working with one company 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 2008.

  • 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 2nd, 3rd and 4th quarters of 2009.

  • MidWest Process Innovation is assisting Chinese and Mexican customers with ISO 13485:2003. We had five successful ISO Certifications during 2008 and two more ISO Certifications are projected for end of 4th quarter, 2008.

  • 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 2008. 

  • John recently wrote articles concerning Purchasing Controls and Change Management. Contact John for a copy of each.

  • Much of MidWest Process Innovation's business efforts have been overseas this year (Europe, Mexico, China, Canada, Pacific Rim), with a continued focus on start-ups with aspirations of becoming compliant with design controls.

 

 

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