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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

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
1/28/2025 15:09
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
1/27/2025 16:24
Case Study
White Paper

Significant Change Within the Context on EU MDR

This white paper summarizes the significant changes and the changes that could jeopardize valid Directive 93/42/EEC (MDD) or 90/385/EEC (AIMDD) certificates for legacy devices leading to the necessity of applying for a MDR cert prior to the end of the transition period as set by the European Union (EU) Law. This paper also provides an overview summary of the recently updated guidance Medical Device Coordination Group (MDCG) document 2020-3 Rev 1 titled, Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD.

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Regulatory Affairs
Medical Devices
1/24/2025 14:04
White Paper
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
1/24/2025 14:01
Case Study
White Paper

Classification of Digital Health Technologies

This white paper describes obstacles that can be encountered when a product or part of a product is mischaracterized by a manufacturer who determines its technology does not fall under the regulatory oversight of the Food and Drug Administration (FDA).

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Regulatory Compliance
Compliance
Medical Devices
1/24/2025 13:45
White Paper
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