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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

EU MDR Regulatory Submissions

Our client, a Fortune 500 medical device manufacturer, identified hundreds of product families in need of preparation for the transition from the European Medical Device Directive (MDD) to the EU MDR regulation. The ECI team implemented a strong process to support the submission process and track Notified Body review status and responses for this multi-year project.

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Regulatory Affairs
Medical Devices
11/4/2024 14:09
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
11/4/2024 14:09
Case Study
Case Study

Pulse Oximeter Manufacturing Transfer

A Fortune 500 medical device manufacturer was face with an increased demand for its Pulse Oximeter devices during the beginning of the COVID pandemic. This case study describes ECI implementation of a master validation plan to fully implement five production lines in a Costa Rica manufacturing facility.

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

FDA Mock Audit

A mock audit is often requested to assess a company's readiness for FDA inspection. This case study illustrates an example of an ECI mock audit in support of a medical device company's response to an FDA warning letter.

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Quality
Medical Devices
11/4/2024 14:09
Case Study
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