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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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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
9/3/2024 19:44
Industry News
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
9/3/2024 19:44
Case Study
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
9/3/2024 19:44
Case Study
Industry News

FDA Final Guidance on Real-World Data: Key Considerations for EHR and Medical Claims Data in Drug Development

The FDA's new guidance on Real-World Data (RWD) focuses on using Electronic Health Records (EHR) and medical claims data for drug development. Key points include selecting appropriate data sources, clear definitions of study variables, rigorous quality control, and validation of data accuracy to ensure reliable use of RWD in regulatory decisions.

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Regulatory Affairs
Regulatory Compliance
Compliance
Pharmaceutical
9/3/2024 19:44
Industry News
Company News

ECI Appoints New CEO and Unveils Cutting-Edge Testing Laboratory

ECI announces two major developments: Brijesh Patel's appointment as CEO, bringing fresh leadership and strategic vision, and the launch of a state-of-the-art Distribution and Stability Testing Laboratory for Products and Packaging, with the first stage fully functional by Q2-2025, enhancing the company’s ability to deliver top-tier testing solutions for both product and packaging needs.

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Medical Devices
9/3/2024 19:44
Company News
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