Industry
Traceability, quality, and global compliance — engineered into SAP.
UDI traceability, quality management, FDA/MDR compliance, global distribution, and complaint handling — all engineered into SAP for manufacturers where every transaction must be traceable and audit-ready. The gap between a validated SAP system and an unvalidated one is a regulatory finding.
The Challenge
The SAP Challenge in Medical Devices
Medical device manufacturers operate under FDA 21 CFR Part 11, ISO 13485, and EU MDR — a traceability and quality mandate that runs through every SAP process. Complaint handling, UDI registration, and global distribution create data requirements that aging ECC systems weren't designed to meet. And every gap is a potential finding.
SAP Solutions
SAP engineering for medical device manufacturers where UDI traceability, QM integration, and FDA/MDR readiness are baseline requirements.
The credentials get us in the room. The relationship is why clients stay for years.
Why DEBCOR
When you call, we answer.
The reason clients stay with deBCor for years isn't a certification — it's that we pick up the phone. Real white-glove ownership: a senior team that knows your system, answers fast, and treats your landscape like our own. Most of our relationships are measured in years, not projects, because we don't disappear after go-live. We stay, we own it, and we're there when it matters.
We've already solved the problem you're about to hit.
29 years delivering SAP — including the rescues other firms couldn't finish. When something breaks or an audit lands without warning, you want a team that has seen it before, not one learning on your system. One prior firm spent $30M+ over three years on a global insurer's program without a go-live; we delivered North America in five months and unblocked 54 countries.
We bring the IP, so you're not paying us to invent.
We arrive with proprietary tooling — AI-powered code analysis, data migration engines, and accelerators built over three decades. Three patents pending. Faster delivery and lower risk because the hard parts are already built — not invented on your budget.
Senior-Led, Global Delivery.
A senior architect leads your engagement from day one and stays accountable through go-live and beyond — backed by a global team that executes efficiently. Senior judgment on the decisions that matter, efficient delivery on the rest. Not a bait-and-switch where the senior you met disappears after the sale.
We speak medical devices' operational language.
UDI traceability, QM, complaint handling, and FDA/MDR-aligned configurations — engineered by senior people who understand that in medical devices, traceability isn't paperwork, it's patient safety.
Engagement Model
Senior architect on day one
We assign a senior SAP architect to lead every engagement from the first conversation. No bait-and-switch. The person who scopes it builds it — with firsthand SAP experience, not a playbook.
AI-accelerated delivery
Our proprietary AI tooling compresses discovery, code analysis, data migration prep, and documentation. Engagements move faster without cutting corners.
We stay to run what we build
We don't hand back the keys. Post-go-live, we roll directly into Managed Services — keeping the same senior team and institutional knowledge that delivered the project.
We engineer SAP batch and serial number management to carry UDI data end-to-end — from device identification through production, distribution, and field service — with integration to the FDA GUDID and EU EUDAMED registries where required.
Yes. We configure SAP to meet Part 11 requirements — digital signatures, audit trails, access controls, and system validation documentation.
We engineer SAP QM complaint workflows connected to EU MDR and FDA MDR reporting requirements — capture, investigation, CAPA, and regulatory submission tracking in a single auditable process.
Validation-first. We design the migration project with CSV strategy aligned from the outset — not bolted on at the end. IQ/OQ/PQ documentation, change control records, and QA sign-off are built into the project plan, not the punch list.
Notable clients
AI-powered SAP engineering for Public Cloud, S/4HANA, BTP, and integrations.
