PROLIM PLM software gives medical device manufacturers a single, central source of product knowledge connecting mechanical, electronics, and software engineering under one compliant, traceable platform.
Regulatory Ready
Integrated Engineering, Document Management & Compliance in One Environment
Cross-Domain PLM
A Unified Environment for Integrated Mechanical, Electronics & Software Development
Predictable Design Control
Deadlines and Deliverables Tied to Actual Workflow Execution
Risk Mitigated
Re-use, Traceability, and Lifecycle Controls Minimize Overall Program
Risk
Challenges Medical
Device Manufacturers Face
Regulatory Requirements
FDA, CE marking, ISO 13485 – constantly evolving rules across global markets.
Systems Engineering
Mechanical, electronics, and software must work as one – changes in one discipline ripple across all.
Risk Management
ISO 14971 risk management integrated at every stage from design through post-market.
Increasing Competition
Faster product cycles and lower-cost competitors demand smarter, leaner development processes.
Increasing Costs
Rising R&D, compliance, and manufacturing costs that must be absorbed without impacting quality.
Design Traceability
Maintain end-to-end traceability from requirements & design through testing, validation, & regulatory.
How PROLIM PLM
Addresses Each Challenge
Regulatory Requirements
Automated regulatory workflows and document lifecycle traceability ensure every product record meets FDA, CE, and ISO 13485 requirements with full audit trails from design through post-market.
Systems Engineering
World-class CAD and engineering tool integration in a multi-CAD environment connecting mechanical, electronics, and software teams under one product model so all disciplines stay synchronised.
Risk Management
Integrated risk mitigation workflows and lifecycle traceability enable re-use of validated components and processes reducing new programme risk while facilitating future product development.
Competition
Predictable design control tied to actual workflow execution with connected deadlines, deliverables, validation, and verification compresses development timelines without introducing quality risk.
Increasing Costs
Integrating R&D, production, quality, services, and regulatory workflows in one platform eliminates duplication, reduces rework, and cuts the cost of compliance by making it a by-product of good process.
What PROLIM PLM Delivers for
Medical Device Manufacturers
Proper Control Over Development, Manufacturing & Quality
A solid PLM system is the best approach to retain control across all three functions giving programme managers real-time visibility across the full device lifecycle.
Predictable Project Schedules & Budgets
Every milestone is tied to actual work status making budget and timeline forecasting reliable.
Trusted by Medical Device Manufacturers
PROLIM's PLM solutions meet regulatory, engineering, and content and document management compliance requirements across the enterprise.
Multi-CAD Engineering Integration
Facilitating effective product and process development across a multi-CAD environment, without forcing teams onto a single platform.
Document Control & Lifecycle Traceability
Connecting deliverables from R&D, production, quality, services, and regulatory in a single audit-ready environment.
Predictable Design Control with Verification & Validation
Connect deadlines and deliverables directly to workflow execution with built-in validation and verification outputs that keep design control predictable, and auditable.
Insights
Thinking that moves
the industry
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