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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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Case Study

Costa Rica Product Registration

A US medical device manufacturer requested regulatory support to register their products and obtain a Free Sales Certificate in Costa Rica. This case study provides an example of our company's ability to provide in-country representation for product registration in Costa Rica.

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Regulatory Affairs
Medical Devices
3/17/2025 18:53
Case Study
Case Study

FDA Mock Audit

A mock audit is often requested to assess a company's readiness for FDA inspection. This case study illustrates an example of an ECI mock audit in support of a medical device company's response to an FDA warning letter.

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Quality
Medical Devices
3/17/2025 18:53
Case Study
Case Study

Warning Letter: Regulatory Responsibility

Our client, a large medical device company, received several 483 inspectional observations and a subsequent Warning Letter from the United States Food and Drug Administration (FDA). This case study describes ECI's approach to an assessment plan and remediation activities in order to provide a robust proposal for each cited violation.

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Regulatory Compliance
Compliance
Medical Devices
3/17/2025 18:53
Case Study
Case Study

Pulse Oximeter Manufacturing Transfer

A Fortune 500 medical device manufacturer was face with an increased demand for its Pulse Oximeter devices during the beginning of the COVID pandemic. This case study describes ECI implementation of a master validation plan to fully implement five production lines in a Costa Rica manufacturing facility.

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Manufacturing Engineering
Medical Devices
3/17/2025 18:53
Case Study
Case Study

Internal Audits

A small medical device manufacturing company was challenged with maintaining daily Quality System activities, including conducting internal audits. ECI provided support to successfully schedule and execute the company's internal audit program per their procedures.

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Quality
Medical Devices
3/17/2025 18:53
Case Study
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