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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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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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Quality
Regulatory Compliance
Compliance
Medical Devices
11/4/2024 14:09
White Paper
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
11/4/2024 14:09
Company News
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
11/4/2024 14:09
Event
Case Study

Machining Process Transfer

ECI was engaged by a medical device manufacturer to support the transfer project of medical device components, including machined screws and secondary processes, from the planning phase through to production.

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Project Management
Manufacturing Engineering
Quality
Medical Devices
11/4/2024 14:09
Case Study
Case Study

Facilities Project Management and Validations

ECI was contracted by a medical device manufacturer to enhance its production capabilities. The project included remodeling the manufacturing facility, expanding the building to add a new Research and Development (R&D) laboratory, a tooling workshop, and making improvements to increase efficiency in product transfer projects.

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Project Management
Manufacturing Engineering
Quality
Medical Devices
11/4/2024 14:09
Case Study
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