cONSULTING
We don't just give advice. We jump in with your team, take ownership of action items, and make sure the work actually gets done. Every company is different, so we adapt to what you need most, whether that’s evaluating suppliers, tightening up quality processes, or supporting your regulatory and QA/RA teams.
Our goal is simple: give you peace of mind and free you up to focus on growth.
Our Services
Supplier Management & Quality
-Supplier evaluations & capability assessments
-Supplier sourcing, vetting, and onboarding
1.Selection & Evaluation
-Contract and price negotiations
-Supplier Quality Agreements (SQAs) and Master Supply Agreements (MSAs)
-On-site technical and quality assessments
-Process validations (IQ/OQ/PQ) and qualifications
2.Onboarding & Agreements
-Supplier Change Impact Assessments (SCIA)
-Drawing/DFM reviews, FMEA, control plans, gage R&R
-QMS consulting, including supplier management modules and workflows
3.Production & Change Management
4.Performance & Continuous Improvement
-CAPA and SCAR process support
-Ongoing supplier monitoring and scorecards
We help you stay aligned with FDA and ISO requirements so there are no surprises.
What we do:
Compliance with ISO 13485 and ISO 9001
Compliance with FDA 21 CFR Part 820 and Part 1271
Supplier Quality Agreements (SQAs) and Acceptance Activity Contracts (AACs)
Labeling compliance (GTIN, UDI)
Environmental & regulatory risk management (RoHS, REACH, PFAS, eCMA)
Quality & Regulatory Compliance
We lead high-impact workshops that drive real change and align teams.
What we do:
Facilitate Kaizen events that eliminate waste and unlock efficiency
Lead Value Stream Mapping (VSM) sessions to improve flow and identify bottlenecks
Support production ramp planning and scale-up readiness
Drive cross-functional alignment between engineering, quality, and operations
Kaizen Facilitation & Process Optimization
Artificial Intelligence Governance
(AI GRC)
We help MedTech companies use AI responsibly and stay ahead of new regulations.
What we do:
AI gap audits using a blended framework approach (NIST AI RMF, ISO 42001, EU AI Act, U.S. state laws)
Policies and procedures for AI use in regulated environments
Monitoring emerging regulations (EU AI Act, U.S. state laws)
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
“I worked with Greg for a number of years conducting Quality System audits in the medical device industry. He is a thorough and detailed auditor. I would recommend him to perform technical audits/assessments for any company that needs to work and compete in a highly regulated industry.”
-James B.
“Working with StackSafe, we were able to find multiple uses for AI in my business, allowing me to take off one of the many hats I wear as a small business owner. I went into the conversation intending to use AI solely for customer outreach and lead generation, but Greg clearly and comprehensively walked me through the many ways I could leverage AI, tailored for my business. Needless to say I will be coming back to StackSafe for all of my AI needs.”
-Cole S.
“I highly recommend Greg for his exceptional skill implementing continuous improvement programs and processes in the healthcare industry. Greg has a strong understanding of breaking down large project roadmaps into individual deliverables and is very patient, explaining technical things clearly so everyone can understand. Because of his efforts, the processes are now smoother and more efficient. Greg was a real asset to our team.”
-Charlie L.
Recommendations
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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.