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Benefits of Product Design Due Diligence for Successful Integration

Join Shital Patel, COO of ECI, as she shares insights on ensuring value creation through effective product design assessments during acquisitions. Perfect for professionals involved in M&A, product development, and quality assurance in the medical device industry. Thursday, September 26, 12pm EDT

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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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White Paper

How Does the New QMSR Rule Impact Your Organization?

On 02 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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Event

American Pharma Manufacturing & Outsourcing Summit

Network with over 150 pharma leaders and explore strategies to maximize efficiency while remaining compliant.

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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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Industry News

FDA Issued a Guidance on Laboratory Developed Tests for Small Entity Compliance

On June 24, 2024, the U.S. Food and Drug Administration (FDA) issued a Small Entity Compliance Guide (SECG) to assist small entities in complying with FDA regulations as they apply to in vitro diagnostic (IVD) products, including laboratory developed tests (LDTs).

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