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Join ECI at Costa Rica MD Summit 2025 – Booth #57

ECI is heading to the Costa Rica MD Summit 2025! Join us and 60+ global MedTech companies for a day of innovation, networking, and collaboration in one of the world’s fastest-growing medical device ecosystems.

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White Paper

How Does the New QMSR Rule Impact Your Organization?

On 14 FEB 2024, FDA issued the Quality Management System Regulation (QMSR) final rule to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation to harmonize and modernize the regulation.

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Case Study

Transfer Project Ultrasonic Cleaning

ECI was engaged by a medical device manufacturer to support a transfer project of an ultrasonic cleaning process for medical device components from planning through production.

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Case Study

Quality Assurance

In the fast-paced and highly regulated landscape of the medical device industry, the selection of components and suppliers plays a critical role in driving efficiency and ensuring product quality.

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Case Study

Project Management of Design History File Integration via Acquisition

A Fortune 500 medical device manufacturer acquired another medical device company to grow their Urology business unit from a $500 million to a $1 billion organization.

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White Paper

Classification of Digital Health Technologies

This white paper describes obstacles that can be encountered when a product or part of a product is mischaracterized by a manufacturer who determines its technology does not fall under the regulatory oversight of the Food and Drug Administration (FDA).

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