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. We understand that your team might not want to travel, whether domestic or international. But we also understand the importance of on-site audits. If this is a sticking point for you and your company, you’re in the right place.
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 21 CFR Part 820
about us
Founder of StackSafe, Greg has over a decade of experience evaluating suppliers for technical capability, regulatory compliance, and operational excellence across industries like MedTech, aerospace, defense, and structural engineering. He has helped companies such as Boston Scientific, Outset Medical, UTC Aerospace, and General Dynamics streamline supply chains, enhance supplier performance, and solve complex quality challenges.
Greg holds a MicroMaster’s in Supply Chain Management from MIT, a Bachelor’s in Mechanical Engineering from North Dakota State University, and is a certified Six Sigma Green Belt. He also writes and speaks on topics like AI in MedTech, predictive inventory optimization, and compliance with global regulations, making him a trusted expert in supplier evaluation and operational strategy.
MicroMasters Program, Supply Chain Management
ISO 13485:2016 Lead Auditor Trained, 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.