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ECI Recognized as a 2025 Boston Scientific Indirect Sourcing Supplier Award Winner

As part of Boston Scientific’s 2025 Supplier Awards, ECI was honored with the Inclusive Indirect Sourcing Supplier Award, recognizing our team's outstanding performance, responsiveness, and cross-functional collaboration. This acknowledgment highlights the trust and partnership built between ECI and one of the world’s leading medical device innovators.

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Case Study

501(k) Gap Assessment in Response to Warning Letter

A large medical device manufacturer received an FDA 483 Observation and subsequent Warning Letter for failure to establish and maintain a design history file to demonstrate the design was developed in accordance with the approved design plan per 21 CFR820.30(j). This case study summarizes ECI's approach and comprehensive actions to execute the commitments made per the client's response to the FDA.

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

Regulatory Strategy

ECI was engaged by a medical device manufacturer to define a regulatory strategy for a new product development project involving multiple medical devices including an artificial intelligence feature.

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

Risk Management File Conversion for EU MDR & EN ISO 14971

This case study provides an example of a risk management file remediation project starting with an impact assessment and subsequent steps to demonstrate conformance to the state of the art with a process to support alignment of the company quality management system documentation.

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Quality
Risk Management
Regulatory Compliance
Medical Devices
3/17/2025 18:53
Case Study
Case Study

Supplier Quality

ECI was engaged by a medical device manufacturer to conduct an assessment to address FDA 483 Observations and subsequent Warning Letter related to supplier quality issues. This case study describes the planning and remediation activities successfully executed to ensure successful agency re-inspection.

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Quality
Medical Devices
3/17/2025 18:53
Case Study
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