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ECI Unveils Dynamic New Identity: A Fresh Vision for Global Leadership

ECI has announced a strategic rebranding that merges Enhanced Compliance, Inc. and its Costa Rica-based subsidiary CRx Life Sciences into a single entity, aiming to enhance its global presence and innovation in the life sciences industry.

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Case Study

Facilities Project Management and Validations

ECI was contracted by a medical device manufacturer to enhance its production capabilities. The project included remodeling the manufacturing facility, expanding the building to add a new Research and Development (R&D) laboratory, a tooling workshop, and making improvements to increase efficiency in product transfer projects.

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Project Management
Manufacturing Engineering
Quality
Medical Devices
7/26/2024 13:39
Case Study
Case Study

Machining Process Transfer

ECI was engaged by a medical device manufacturer to support the transfer project of medical device components, including machined screws and secondary processes, from the planning phase through to production.

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Project Management
Manufacturing Engineering
Quality
Medical Devices
7/18/2024 18:14
Case Study
Event

Insights from an FDA Expert: Mastering Medical Device Complaint Handling

Watch this recording to enhance your understanding of medical device complaint handling. Learn the critical insights shared by an FDA insider expert on how to navigate the complexities of complaint management, including the biggest deficiencies flagged by the FDA and key strategies to ensure patient safety and regulatory compliance.

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Post Market Surveillance & Vigilance
Medical Devices
7/17/2024 18:46
Event
Industry News

Periodic Update European Commission’s on Phthalates in Certain Medical Devices

The Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) updated its guidelines on the benefit-risk assessment (BRA) of the presence of phthalates in certain medical devices covering phthalates which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine-disrupting (ED) properties. The MDR (EU 2017/745) requires adequate justification for use in medical devices.

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Regulatory Affairs
Medical Devices
7/17/2024 18:46
Industry News
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
7/17/2024 17:52
Case Study
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