Insights

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

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

9/3/2024 19:44

White Paper

Significant Change Within the Context on EU MDR

This White Paper summarizes the significant changes and the changes that could jeopardize valid Directive 93/42/EEC (MDD) or 90/385/EEC (AIMDD) certificates for legacy devices leading to the necessity of applying for a MDR cert prior to the end of the transition period as set by the European Union (EU) Law. This paper also provides an overview summary of the recently updated guidance Medical Device Coordination Group (MDCG) document 2020-3 Rev 1 titled, Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD.

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Regulatory Affairs

Medical Devices

9/3/2024 19:44

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

9/3/2024 19:44

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

9/3/2024 19:44

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

9/3/2024 19:44

White Paper

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Featured

Benefits of Product Design Due Diligence for Successful Integration

Posts

Roadmap to Medical Device Recalls

Significant Change Within the Context on EU MDR

The Fundamentals of Medical Device Complaint Handling

The Key to Interpretation for FDA Guidance

The Regulatory Crux with Artificial Intelligence as a Medical Device

ECI on LinkedIn & Twitter

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Benefits of Product Design Due Diligence for Successful Integration

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Industry

Roadmap to Medical Device Recalls

Significant Change Within the Context on EU MDR

The Fundamentals of Medical Device Complaint Handling

The Key to Interpretation for FDA Guidance

The Regulatory Crux with Artificial Intelligence as a Medical Device

ECI on LinkedIn & Twitter

Who We Serve

Our Reliable Solutions

Let Us Help