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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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White Paper

What to Expect During an FDA Inspection and How to Prepare

It is imperative that a firm be ready for the FDA to enter their facilities to conduct an inspection at any reasonable time. This white paper explains to the medical device industry about what to expect from the FDA during an inspection and how to prepare for such an event. It also addresses what not to do during an FDA inspection.

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Quality
Regulatory Compliance
Medical Devices
9/3/2024 19:44
White Paper
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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Regulatory Affairs
Medical Devices
9/3/2024 19:44
White Paper
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
9/3/2024 19:44
White Paper
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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Project Management
Medical Devices
9/3/2024 19:44
Case Study
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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Quality
Pharmaceutical
9/3/2024 19:44
Case Study
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