Production-Ready Compliance for Medical Device Manufacturers
Next Plus automates Device History Records, enforces qualified operator access, and delivers complete traceability — so you can focus on building life-saving devices, not chasing paperwork.
Faster DHR Completion
Fewer Errors
Audit Readiness
Compliance Rate
Industry Challenges We Solve
Medical device manufacturing faces some of the strictest regulatory requirements in the world. Next Plus is built to handle them.
FDA 21 CFR Part 11
Maintain electronic records and signatures that fully satisfy FDA requirements, with tamper-proof audit trails for every action.
Device History Records
Automate DHR generation and ensure every required data point is captured at the point of production — no manual assembly.
ISO 13485 Compliance
Implement the quality management processes required by ISO 13485, from document control to CAPA management.
Traceability & Recall
Track every component, lot, and serial number from incoming inspection to final device. Run recall analyses in seconds.
Operator Qualification
Ensure only trained and qualified personnel perform critical operations. Track certifications and block unqualified access.
Change Control
Manage engineering changes with full approval workflows. Operators see updated instructions the moment a change is approved.
How Next Plus Helps
Purpose-built solutions for aerospace and defense manufacturing excellence
Automated Device History Records
Replace paper travellers and manual DHR assembly with a digital record that builds itself during production. Every step, signature, and data point is captured automatically.
- Auto-generated DHR from production data
- Electronic signatures — 21 CFR Part 11 compliant
- Batch and serial traceability built in
- Instant export for audits and submissions
Quality Management & CAPA
Embed inspection checkpoints into every work instruction. Log non-conformances in the moment, route them for disposition, and track CAPA closure — all in one system.
- Inline inspections at each production step
- NCR and deviation management workflows
- CAPA tracking from initiation to closure
- Real-time quality dashboards by product and line
Built for Regulated Medical Device Manufacturing
Next Plus is designed to meet the strictest quality and documentation requirements in the medical device industry — from small MDMs to global manufacturers.
Electronic Records
Tamper-proof, timestamped records for every action across the production floor.
e-Signatures
21 CFR Part 11 compliant with full authentication and audit logging.
Document Control
Version-controlled work instructions with approval workflows and controlled release.
Training Qualification
Block unqualified operators and maintain training records automatically.
Ready to Modernize Your Medical Device Operations?
See how Next Plus eliminates paperwork, enforces compliance, and keeps you audit-ready. Anti-MES
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