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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

Device Clearance in Less Than 90 Days: Analysis & Tips

The 90-Day window to an FDA clearance is everyone's goal. The following analysis on submission timeframes and tips to providing responses to the questions on a 510(k) submission may be of interest when planning your next submission.

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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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Case Study

Project Management of Design History File Integration via Acquisition

A Fortune 500 medical device manufacturer acquired another medical device company to grow their Urology business unit from a $500 million to a $1 billion organization.

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Case Study

Quality Assurance

In the fast-paced and highly regulated landscape of the medical device industry, the selection of components and suppliers plays a critical role in driving efficiency and ensuring product quality.

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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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