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Benefits of Product Design Due Diligence for Successful Integration

Join Shital Patel, COO of ECI, as she shares insights on ensuring value creation through effective product design assessments during acquisitions. Perfect for professionals involved in M&A, product development, and quality assurance in the medical device industry. Thursday, September 26, 12pm EDT

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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
9/3/2024 19:44
Case Study
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
9/3/2024 19:44
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
9/3/2024 19:44
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
9/3/2024 19:44
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
9/3/2024 19:44
White Paper
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