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

ECI is heading to the Costa Rica MD Summit 2025! Join us and 60+ global MedTech companies for a day of innovation, networking, and collaboration in one of the world’s fastest-growing medical device ecosystems.

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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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Regulatory Affairs
Medical Devices
3/17/2025 18:53
White Paper
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
3/17/2025 18:53
White Paper
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
3/17/2025 18:53
White Paper
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
3/17/2025 18:53
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
3/17/2025 18:53
Case Study
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