Medical Device Manufacturing Software
Finite capacity scheduling for medical device manufacturers. FDA 21 CFR Part 11 audit trails, ISO 13485 traceability, multi-level BOMs, and clean-room aware scheduling — built for regulated production.
Medical Device Manufacturing Scheduling Challenges
Medical device manufacturing combines high-mix, low-volume production with the strictest regulatory requirements in manufacturing. FDA 21 CFR Part 11, ISO 13485, design history files, and full lot traceability are non-negotiable. Meanwhile, sterilization cycles, clean rooms, and operator certifications add scheduling constraints that generic ERP modules cannot handle.
- FDA 21 CFR Part 11 electronic records and audit trail requirements
- ISO 13485 quality management and full traceability
- Multi-level BOMs (10+ levels deep for complex devices)
- Sterilization cycles (autoclave, ETO, gamma) as long-cycle operations
- Operator certifications constrain who can run regulated steps
- Clean-room time and gowning windows as schedulable constraints
How RMDB Serves Medical Device Manufacturers
RMDB delivers the finite-capacity scheduling layer regulated medical device manufacturers need on top of their existing ERP and QMS. It handles 10-level BOMs, sterilization cycles, certified-operator constraints, and full lot traceability — all with the audit trail required for Part 11 compliance.
- FDA 21 CFR Part 11 audit trail and electronic signatures
- ISO 13485 compatible production traceability
- 10+ level deep multi-level BOM scheduling
- Sterilization and clean-room cycle modeling
- Operator certification matrices for regulated steps
- Integrates with Plex, QAD, Dynamics, NetSuite, SAP, and Epicor
- Lot genealogy from raw material to finished device
- One-time license — no per-user monthly subscription fees
Proven Results in Regulated Manufacturing
10-Level
Deep multi-level BOM scheduling proven in regulated production
Enevate Corporation
Part 11
Audit trail and electronic signature support
FDA Compliance
5 Days
From kickoff to live finite-capacity schedule
Standard Implementation
$5K
One-time license — no per-user fees
Pricing Starting Point
Frequently Asked Questions
Regulated Manufacturing Success Stories
See how regulated manufacturers use RMDB for compliant, multi-level production scheduling.
Explore Related Solutions
Discover how these capabilities work together to transform your manufacturing operations.
Bill of Materials (BOM)
Multi-level BOM management tied to scheduling
Learn moreFinite Capacity Scheduling
Schedule to real machine, labor, and material limits
Learn moreERP Integration
Bi-directional data sync with SAP, Oracle, Epicor, and more
Learn moreMaster Production Schedule
Long-horizon capacity planning and MPS generation
Learn moreLabor Scheduling
Workforce capacity planning alongside machines
Learn moreReady to fix your medical device production schedule?
Get a live demo with your real BOMs, sterilization cycles, and certification requirements. See FDA-compliant finite-capacity scheduling running on your actual production data.