Case Studies and Field Success Stories

Real success stories demonstrating how proper guidance from an NPI expert in medical devices leads to business results, shortened time-to-market, and compliance with the most stringent regulatory standards.

NPI process in medical devices

Complex NPI Process

How we led the transition from development to manufacturing of an advanced medical imaging system, while meeting tight schedules and solving technological challenges on the production line.

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Regulatory approvals for design changes

Regulation and Design Changes

A case study on obtaining regulatory approvals for substantial design changes in a life-saving device, while maintaining the existing technical file and minimizing regulatory risks.

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PLM systems implementation

PLM Systems Implementation

An implementation story of a Product Lifecycle Management (PLM) system in a medical startup company, which created order in documentation and engineering change management.

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