Supplier Quality, Covered.
StackSafe builds medical device supplier management programs and provides the Supplier Quality Engineers (SQEs) to run it.
Two ways to work with StackSafe
For quality and RA leaders who need to implement a supplier program sized to their team.
▪ Supplier management procedures aligned with ISO 13485 §7.4 purchasing controls
▪ Supplier risk classification and ASL cleanup
▪ Quality agreements and supplier scorecards
▪ Supplier audits
▪ Front and back-room support during FDA inspections and ISO audits
For quality managers with a backlog of supplier work and no open headcount. Our engineers know the work and start contributing day one.
▪ Supplier onboarding and RoHS/REACH gathering
▪ Supplier change requests and impact assessments
▪ SCARs, from root cause through VOE
▪ Validation (IQ/OQ/PQ) and process control plan reviews
▪ Supplier audits, re-evaluations, and nonconformances
400 South 4th St.
Minneapolis, MN, 55415
Built for small and mid-size device companies who are:
Recently cleared or funded
You have FDA clearance/approval, and supplier controls need to catch up.
In the middle of a submission
Supplier controls in place before the first inspection.
Between SQE hires
Supplier quality keeps moving while you recruit.
Facing a surge
A wave of supplier onboarding or open SCARs, handled without adding headcount.
Too small for a full-time SQE
Part time support for a handful of supplier audits/SCARs/monitoring.
Contact Us
Send us an email at contact@stacksafe.com or book a call below.
Let’s spend 20 minutes on your supplier quality situation. Tell me where things stand: no program yet, a QMSR gap, or more supplier work than your team can handle.
I’ll give you my recommendation and practical next steps.
Greg Matson
Owner & Principal Quality Consultant
Greg Matson is the owner of StackSafe, where he helps medical device companies implement supplier management programs. He built his foundation in supplier quality at Boston Scientific and has since worked with companies of every size, from global manufacturers to 10-person startups, on Class I, II, and III devices ranging from surgical tools to active implantables. Greg is a certified ISO 13485 Lead Auditor and a mechanical engineer with an MIT MicroMasters in Supply Chain Management.