Medical devices
Quality systems, plant ramp-ups, and supply assurance for regulated manufacturing.
- Case studies
- 1
- Insight pieces
- 2
- Practice leads
- 3
Medical device manufacturers balance two clocks: regulatory timelines and production ramp curves. We help clients plan both, from design transfer documentation to cleanroom capacity, with quality management as a design input rather than a final gate.
The practice works under ISO 13485 and FDA process rules daily, and publishes on the operational side of audits: how documentation, training, and supplier controls actually run on a busy line.
Capabilities applied here
Case studies in this industry
Insight from this sector
Who leads this practice
Priya Natarajan
Partner · Singapore
Regulated ramp-ups and design transfer
engineering-npisupply-chain-resilience
Chiara Rovelli
Principal · Rotterdam
Quality systems that run at production speed
operations-performancesupply-chain-resilience
Leila Karimi
Principal · Singapore
Process utilization and water-energy systems
operations-performancesustainability-and-energy
Working in medical devices?
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