Examples of success
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
EU Medical Device Regulations
- Identified gaps in current MDD Technical Documents
- Identified gaps in the Quality Management System procedures and processes
- Created a project plan using monday.com to track the project
ISO 14971:2019 Risk Management
- Created a training program to train Engineering, Operations, Quality, and Regulatory
- Updated Risk Management Plans, Hazard Identification, Risk Analysis, and Risk Management Reports
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.