PLM Implementation for Medical Device Manufacturers
Connect design to manufacturing with complete traceability for FDA compliance. 21 CFR Part 11 ready, ISO 13485 certified. From design controls through production to post-market surveillance—digital thread for device lifecycles. 18 successful transformations.
Products require FDA clearance before launch. Every component must be traced from raw material to patient. And a single quality issue can trigger Class I recalls, FDA warning letters, or loss of market authorization.
Generic PLM implementations fail medical device manufacturers because they don't understand Design History File requirements, electronic record regulations (21 CFR Part 11), or the reality that your regulators expect complete traceability with ironclad documentation for devices that may be implanted in patients for decades.
Element Consulting specializes in PLM for medical device manufacturers. We've implemented systems for 18 medical device companies—from Class I to Class III devices across diagnostics, implants, and therapeutic equipment—with 100% ISO 13485 audit pass rate and average 40% reduction in FDA submission time.
Medical Devices Case Studies
*Results reflect specific project implementations and may vary based on organizational factors and scope.
What makes us different:
Three things our clients mention when they refer us:
Partnership, not information
Process-First Integration
OCM Adoption
FAQ
How does PLM support post-market surveillance and vigilance?
What if we're transitioning from paper-based Design History Files?
How do you handle combination device-drug products in PLM?
Can PLM speed up 510(k) or PMA submissions?
What's the difference between PLM for Class I vs Class III devices?
How long does medical device PLM implementation typically take?
Can PLM handle lot-to-patient traceability for medical devices?
How does PLM support FDA 21 CFR Part 11 compliance?
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