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
Engineering, Document Management and Compliance Built in
Cross-Domain PLM
Mechanical · Electronics · Software in One Environment
Predictable Design Control
Deadlines and Deliverables Tied to Actual Workflow Execution
Risk Mitigated
Re-use, Traceability, and Lifecycle Controls Reduce Programme 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.
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