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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

Costa Rica Product Registration

A US medical device manufacturer requested regulatory support to register their products and obtain a Free Sales Certificate in Costa Rica. This case study provides an example of our company's ability to provide in-country representation for product registration in Costa Rica.

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

Warning Letter: Post Market Surveillance Remediation

ECI was enlisted to guide a large medical device company through remediation planning and execution to comprehensively address FDA 483 observations and subsequent Warning Letter, due to deficiencies in post-market surveillance activities.

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Regulatory Compliance
Post Market Surveillance & Vigilance
Medical Devices
11/4/2024 14:09
Case Study
Case Study

Post Market Surveillance Resource Management

ECI was enlisted to guide a large medical device company through 483 Observation and Warning Letter remediation planning for post-market surveillance activities. In parallel to the remediation efforts, ECI also supported the company's acquisition by a competitor to ensure a seamless transition aligning the company's procedures for complaint processing and medical device reporting.

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Regulatory Compliance
Post Market Surveillance & Vigilance
Medical Devices
11/4/2024 14:09
Case Study
White Paper

Responding to FDA Objectionable Conditions: FDA-483s and Warning Letters

ECI released this white paper to better inform the medical device industry about how to most effectively respond to objectionable findings from the FDA generated as a result of Agency inspections or investigations.

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Regulatory Compliance
Medical Devices
11/4/2024 14:09
White Paper
White Paper

Roadmap to Medical Device Recalls

When an FDA-regulated product is defective or potentially harmful, the most effective means for protecting the public is to correct the problem or remove the product from the market. This white paper provides guidance on what to do when a company learns that there is a problem with one of their medical devices.

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Quality
Regulatory Compliance
Post Market Surveillance & Vigilance
Medical Devices
11/4/2024 14:09
White Paper
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