Field notesfrom the regulated floor.
Whitepapers and field notes — one continuous argument for what regulated manufacturing should feel like in 2026. Start at the top, or jump to the entry that's biting you this week.
- 01Whitepaper
From Prototype to Production
What SMEs (10–250 employees) need to move from prototype to full‑scale production in an innovative, compliant, and sustainable way.
10 pages · PDF - 02Document control
If It's Not Documented, It Didn't Happen
The FDA's golden rule, and why "we'll just stay organized" usually falls apart under review.
9 min read - 03Traceability
FDA Approval Demands Complete Traceability From Supplier to Patient
It's 3 AM and the FDA is calling. The difference between a contained issue and a real regulatory problem is one report.
10 min read - 04Whitepaper
ERP Strategies to Navigate Compliance in MedTech
The ERP features fast‑growing MedTech companies need for market readiness, and why software designed specifically for MedTech is non‑negotiable.
9 pages · PDF - 05Surgical kits
Finding an FDA-Compliant ERP System for Surgical Device Production
Your surgical kit has 47 components. The FDA wants to trace them all — by lot, by expiration, by sterilization batch.
9 min read - 06PLM ↔ ERP
Design Control is Not Production Control
Your PLM and ERP don't talk to each other — and the FDA noticed. Why PLM evaluation should start with the ERP integration question.
10 min read - 07FDA experience
Why Your ERP Should Be Built by Folks Who Know FDA Approval
"We'll figure it out together" — famous last words. FDA experience isn't a nice-to-have on an implementation team.
8 min read - 08Budget
Big ERP Capabilities on a Small Budget
The scariest part of ERP for most med-tech startups isn't the implementation — it's the quote. It doesn't have to be.
9 min read