ERP Software for Medical Device Manufacturing
ProShop ERP is purpose-built for medical manufacturers who demand traceability, rigorous quality control, and real-time visibility. Trusted by FDA- and ISO 13485-compliant shops, ProShop helps you streamline documentation, eliminate paper, and deliver life-saving parts with confidence.
100%
Paperless job travelers, inspection records, and cert packages—no more binders
0
Non-conformances found in customer FDA or ISO audits after switching to ProShop
30%
Average reduction in time spent on compliance and quality documentation
How ProShop Helps Medical Manufacturers
Micro Headline: FDA & ISO 13485 Compliance Made Simple
ProShop’s embedded QMS automates documentation, integrates inspection data, and maintains airtight version control—so your team can focus on quality parts, not paperwork.
- Built-in ISO 13485 & FDA 21 CFR Part 11 support
- Complete training records and revision control
- Integrated NCRs, CARs, and document logs
100% Digital Traceability
Track every step of your process from raw material to finished part. With instant access to certs, inspections, and job history, you’re always ready for FDA, ISO, or customer audits.
- Full digital record of parts, certs, and processes
- Instant traceability reports in a few clicks
- Reduced audit prep from days to minutes
All-in-One ERP, MES, and QMS
ProShop connects your production, quality, and business operations in one platform—so you can work faster, safer, and with complete confidence.
- Eliminate duplicate entry and spreadsheet chaos
- Shared data across scheduling, inventory, and inspection
- Visual WIP and job status for the whole team
Success Stories
Explore all of our products and features
Discover the fully integrated tools that help your shop increase productivity, boost revenue, and cut costs — all from a single paperless platform.
Enterprise Resource Planning (ERP)
Run your shop in one system. ProShop replaces spreadsheets with a fully digital workflow built for precision manufacturers.
Manufacturing Execution System (MES)
Track jobs, parts, and processes in real-time with live data, visual scheduling, and shop floor control—all in one MES.
Quality Management System (QMS)
Be audit-ready always. ProShop’s built-in QMS delivers full traceability, document control, and compliance with ISO 13485, ISO 9001, or AS9100