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Join ECI at Vistatec’s Upcoming Webinar on Laboratory Developed Tests (LDT)

ECI is proud to take part in an expert panel at Vistatec’s upcoming webinar on Laboratory Developed Tests (LDT). Join us on May 21 as our Senior Regulatory Manager, Sean McCarthy, shares insights on navigating today’s evolving LDT regulatory landscape.

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Event

How to Ensure Quality in Nearshoring Transfer of a Product

On November 26 2024, Lucía Meza, Senior Engineering Consultant, shared key strategies for maintaining quality in nearshoring medical product transfers. The session covered best practices for the medical and biopharma industries, with practical insights and a live Q&A. Watch the recording to learn more!

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