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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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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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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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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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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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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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