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Benefits of Product Design Due Diligence for Successful Integration

Join Shital Patel, COO of ECI, as she shares insights on ensuring value creation through effective product design assessments during acquisitions. Perfect for professionals involved in M&A, product development, and quality assurance in the medical device industry. Thursday, September 26, 12pm EDT

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Benefits of Product Design Due Diligence for Successful Integration

Join Shital Patel, COO of ECI, as she shares insights on ensuring value creation through effective product design assessments during acquisitions. Perfect for professionals involved in M&A, product development, and quality assurance in the medical device industry. Thursday, September 26, 12pm EDT

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Research & Development
Regulatory Compliance
Mergers & Acquisitions Support
Medical Devices
9/16/2024 10:09
Event
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
9/13/2024 11:40
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
9/13/2024 11:40
Event
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
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
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