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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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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
1/21/2025 12:40
Case Study
Case Study

Warning Letter: Regulatory Responsibility

Our client, a large medical device company, received several 483 inspectional observations and a subsequent Warning Letter from the United States Food and Drug Administration (FDA). This case study describes ECI's approach to an assessment plan and remediation activities in order to provide a robust proposal for each cited violation.

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Regulatory Compliance
Compliance
Medical Devices
1/21/2025 12:12
Case Study
Case Study

Internal Audits

A small medical device manufacturing company was challenged with maintaining daily Quality System activities, including conducting internal audits. ECI provided support to successfully schedule and execute the company's internal audit program per their procedures.

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Quality
Medical Devices
1/16/2025 12:05
Case Study
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
1/10/2025 14:38
White Paper
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
1/8/2025 14:06
Event
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