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MPO Medtech Forum 2025

ECI is proud to sponsor the MPO Medtech Forum on April 24-25 at the Costa Rica Convention Center in San Jose.

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Case Study

Regulatory Assessment of Product Portfolio

ECI helped a medical device manufacturer reclassify its telehealth devices from Class I to Class II. This included a gap assessment of QMS and a regulatory strategy, resulting in a clear pathway for market expansion.

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

Regulatory Support to New Product Development Project

ECI assisted a medical device firm in developing a cloud platform for remote patient care, covering data flow, regulatory strategy, and FDA pre-submission. ECI ensured compliance with FDA and NIST standards and provided essential documentation for the client's digital health solutions.

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

Regulatory Submission Review

Discover how ECI’s expert team navigated regulatory complexities to expedite product approvals in our latest case study. Learn about the tailored strategies and impactful solutions we implemented to streamline compliance and support our client’s success. Read more to see how we can help you achieve regulatory milestones efficiently.

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

Why Stability and Performance Testing Should Be Separate for Medical Devices

Did you miss the live session? Access the full recording here. Join Laura Vargas, Principal Engineering Consultant, as she discusses why stability and performance testing for medical devices should be conducted separately despite long-standing industry practices.

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Technical Services
Medical Devices
3/17/2025 18:53
Event
Event

Benefits of Product Design Due Diligence for Successful Integration

Is your organization considering an acquisition? Or have you recently completed one? In this session, Shital Patel will discuss the critical importance of assessing product designs pre and post-acquisition. Missed the live session? Access the full recording here.

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Research & Development
Regulatory Compliance
Mergers & Acquisitions Support
Medical Devices
3/17/2025 18:53
Event
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