Insights

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

3/17/2025 18:53

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

3/17/2025 18:53

White Paper

The Regulatory Crux with Artificial Intelligence as a Medical Device

This white paper discusses the current regulatory state and highlights critical quality practices for AI medical products.

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Regulatory Affairs

Medical Devices

3/17/2025 18:53

White Paper

The Key to Interpretation for FDA Guidance

Guidance documents are prepared by Food and Drug Administration (FDA) staff to describe the Agency’s current thinking or policy on a particular Regulatory issue. This white paper provides recommendations for industry to consider when interpreting an FDA guidance document.

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Regulatory Affairs

Medical Devices

3/17/2025 18:53

White Paper

The Fundamentals of Medical Device Complaint Handling

The complaint handling process for medical device manufacturers is of fundamental importance for multiple reasons. This white paper will help you comprehend and effectively handle your company’s complaints from their opening through the closing of the complaint.

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Quality

Post Market Surveillance & Vigilance

Medical Devices

3/17/2025 18:53

White Paper

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Posts

Device Clearance in Less Than 90 Days: Analysis & Tips

What to Expect During an FDA Inspection and How to Prepare

The Regulatory Crux with Artificial Intelligence as a Medical Device

The Key to Interpretation for FDA Guidance

The Fundamentals of Medical Device Complaint Handling

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Featured

Join ECI at Costa Rica MD Summit 2025 – Booth #57

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Service

Industry

Device Clearance in Less Than 90 Days: Analysis & Tips

What to Expect During an FDA Inspection and How to Prepare

The Regulatory Crux with Artificial Intelligence as a Medical Device

The Key to Interpretation for FDA Guidance

The Fundamentals of Medical Device Complaint Handling

ECI on LinkedIn & Twitter

Who We Serve

Our Reliable Solutions

Let Us Help