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AMD Summit 2024

This Summit features over 200 senior leaders from all the top device companies in the industry for two days of networking and learning best practices.

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Event

AMD Summit 2024

This Summit features over 200 senior leaders from all the top device companies in the industry for two days of networking and learning best practices.

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Medical Devices
9/5/2024 16:36
Event
Event

Insights from an FDA Expert: Adapting to the New Laboratory Developed Test Regulations

If you missed our recent event, you can still access valuable insights from Sonia Lecce, Senior Regulatory Consultant, on the FDA's new LDT (Laboratory Developed Test) ruling.

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Research & Development
Regulatory Compliance
Medical Devices
9/4/2024 11:24
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
9/3/2024 19:44
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
9/3/2024 19:44
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
9/3/2024 19:44
Case Study
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