Examples of success

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ISO 13485:2016 and MDSAP Implementation

  • Created plan for client to obtain ISO/Medical Device Single Audit Program (MDSAP) certification in five months.  
  • Performed internal audits, created gap analysis and quality plan.
  • Rewrote procedures to make more "user friendly" while meeting the requirements 
  • Performed training sessions for the entire company
  • Client was complimented by the Notifying Body on the improvements made and was certified with only two minor findings


Inventory Reduction using Lean Tools

  • Implemented an electronic inventory system in four US sites, manufacturing in Malaysia and Distribution in Germany
  • Eliminated $975,000 in twelve months, increase inventory turns by 91% and had less than 0.5% stock outs

Supplier Quality Management

  • Fortune 100 company asked for help with newly formed Supplier Quality Team
  • Conducted Voice of the Customer Surveys from key stakeholders in the company
  • Led the team through the analysis and created the five year project plan with key metrics tied to the business

ISO 13485:2016 multi-site implementation

  • Put together plan for ISO certification for sites in Canada, Florida, North Carolina and Massachusetts.
  • Negotiated with ISO Registrars to consolidate to one source which saved considerable amount of money.
  • Rewrote procedures and created processes that were "right sized" to the specific sites.
  • Hired Quality Leads at each site to sustain the work.
  • Client was complimented by the ISO Auditor on the vast improvements made to the Quality Management System.
  • Client obtained ISO certification with a total of three findings for all of the sites.

Supplier Audit Support

  • Client was issued a Warning Letter from FDA for not performing supplier audits of critical outsourced processes
  • Worked with several suppliers to coordinate the audits, perform the audits and submit the reports and findings.
  • Client was able to address all the findings from FDA within the time period required.

Proactive Supplier Management Publication

  • Working with a colleague and fellow Veteran, we co-authored our book on "Proactive Supplier Management in the Medical Device Industry."
  • The entire process took 15 months, including three independent peer reviews.
  • Over five hundred copies have been sold to date. 
  • 100% of the royalties are donated to Veteran support organizations.