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Case Study

Regulatory Assessment of Product Portfolio

ECI helped a medical device manufacturer reclassify its telehealth devices from Class I to Class II. This included a gap assessment of QMS and a regulatory strategy, resulting in a clear pathway for market expansion.

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Regulatory Compliance
Medical Devices
11/15/2024 17:40
Case Study
Event

How to Ensure Quality in Nearshoring Transfer of a Product

Join us on Tuesday, November 26, at 11:00 am EST as Lucía Meza, Senior Engineering Consultant, shares essential strategies for ensuring quality in nearshoring medical product transfers. Gain insights into planning, execution, and best practices for the medical and biopharma industries. Don’t miss the live Q&A!

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Technical Services
Medical Devices
11/13/2024 14:19
Event
Event

Why Stability and Performance Testing Should Be Separate for Medical Devices

Did you miss the live session? Access the full recording here. Join Laura Vargas, Principal Engineering Consultant, as she discusses why stability and performance testing for medical devices should be conducted separately despite long-standing industry practices.

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Technical Services
Medical Devices
11/4/2024 16:30
Event
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
11/4/2024 14:09
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
11/4/2024 14:09
Case Study
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