We find gaps before the REgulators do.
There aren’t many auditors who are engineers. We’ve been on the operations side, and we know how to spot the gaps. The difference in engineering-led audits is that we can uncover the real issues in design, production, quality, and compliance before they cost you time, money, and regulatory trouble.
What sets us apart?
We travel to suppliers, so you don’t have to. Your team is managing a million priorities, and the last thing you need is to pull resources away for supplier-audit travel. That’s where we come in.
Industries We
Work With
Medical
Device
Class I, II, and III devices,
tissue banks, and more.
Industrial
Manufacturing
Aerospace, Defense,
Automotive, and more.
Recommendations
Services
Hourly consulting
Supplier Management & Quality, QA/RA, Kaizen Events
Internal & supplier audits
Engineering Led ISO 13485/9001, FDA QMSR
about us
Founder of StackSafe, Greg specializes in MedTech auditing, supplier quality, and regulatory compliance. With over a decade of hands-on experience assessing suppliers for conformance, quality system maturity, and manufacturing capability, he has supported organizations such as Boston Scientific, Outset Medical, UTC Aerospace, and General Dynamics in strengthening their QMS, improving supplier performance, and resolving complex compliance issues across MedTech, aerospace, defense, and advanced manufacturing.
Greg is a PECB Certified ISO 13485 Lead Auditor and holds a MicroMaster’s in Supply Chain Management from MIT as well as a Bachelor’s in Mechanical Engineering from North Dakota State University. A certified Six Sigma Green Belt, he regularly writes and speaks on quality systems, internal and supplier audits, and AI’s role in MedTech compliance, making him a trusted expert in regulatory readiness and supplier assurance.
MicroMasters Program, Supply Chain Management
Certified ISO 13485 Lead Auditor, PECB
AI Strategy and Governance Certificate
Six Sigma Green Belt
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Internal audits evaluate your company’s own processes and QMS compliance, while supplier audits assess your vendors’ ability to meet product and possibly ISO 13485/9001 requirements. Both are essential for identifying risks and ensuring compliance.
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ISO 13485/9001 and FDA 21 CFR Part 820 require suppliers to be re-evaluated periodically, with frequency based on risk. Critical suppliers are often evaluated every 12 to 24 months, while lower-risk suppliers may be on a longer cycle. Perform a risk mapping exercise to determine supplier risk.
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Independent auditors provide objectivity, technical expertise, and industry perspective. Engineering-led audits go beyond checklists- spotting gaps in design, operations, and compliance that internal teams may overlook.
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Findings are documented in a report and categorized by non-conformity. You’ll need to develop a corrective action plan, track progress, and verify effectiveness to close the finding. After auditing, we can help develop and implement corrective actions, track progress, and verify effectiveness to fully close the findings.