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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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Event

Insights from an FDA Expert: Mastering Medical Device Complaint Handling

Watch this recording to enhance your understanding of medical device complaint handling. Learn the critical insights shared by an FDA insider expert on how to navigate the complexities of complaint management, including the biggest deficiencies flagged by the FDA and key strategies to ensure patient safety and regulatory compliance.

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Post Market Surveillance & Vigilance
Medical Devices
3/17/2025 18:53
Event
Company News

ECI Unveils Dynamic New Identity: A Fresh Vision for Global Leadership

ECI has announced a strategic rebranding that merges Enhanced Compliance, Inc. and its Costa Rica-based subsidiary CRx Life Sciences into a single entity, aiming to enhance its global presence and innovation in the life sciences industry.

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Medical Devices
3/17/2025 18:53
Company News
Event

Best Practices in Successful Product Design Acquisition Integration

Orla Blount, Sr. Director of Business Development, Shital Patel, Chief Operating Officer & Sr. VP of Operations, and Maylin Truesdell, Director of Regulatory Affairs, of ECI led a plenary session at the AMD Summit 2024 on the value of pre-acquisition due diligence and post-acquisition gap assessments. Access the full recording here.

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Mergers & Acquisitions Support
Medical Devices
3/17/2025 18:53
Event
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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Quality
Regulatory Compliance
Compliance
Medical Devices
3/17/2025 18:53
White Paper
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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Manufacturing Engineering
Medical Devices
3/17/2025 18:53
Case Study
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