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.
- 01Budget
Yes, Medical Device Companies Seeking FDA Approval CAN Get Big ERP Capabilities on a Small Budget
Enterprise-level ERP capabilities do not have to mean enterprise-level cost. The right medical device ERP should support regulated manufacturing now and scale after clearance, approval, or launch.
6 min read - 02MedTech ERP support
Why Your Medical Device ERP System Should Be Supported by People Who Know Med Tech Manufacturing
Your regulated manufacturing environment should not be your vendor’s first. Industry experience shows up in implementation decisions, support conversations, and the everyday details of scaling a med tech business.
5 min read - 03Documentation strategy
Seeking FDA Approval? If It's Not Documented, It Didn't Happen
As FDA approval gets closer, documentation becomes more than a submission task. PLM, QMS, and ERP need to connect approved design data, quality evidence, and live operational records.
5 min read - 04Traceability
FDA-Regulated Growth Demands ERP With Complete Traceability From Supplier to Hospital
FDA-regulated growth demands a traceability chain from supplier lot to finished device, shipment, customer, hospital, and—in some cases—patient.
6 min read - 05Surgical devices
Finding the Right ERP System for FDA-Regulated Surgical Device Production
Surgical device production brings specialized traceability, sterility, consignment, expiration, and kit-management requirements that generic ERP systems were not built to handle.
5 min read - 06PLM ↔ ERP
Design Control is Not Production Control: Why Your Medical Device ERP System Needs Both
Design control and production control are distinct but connected. Your PLM choice should be made with ERP integration in mind before manufacturing scale exposes the gap.
7 min read - 07Whitepaper
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 - 08Whitepaper
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