We Make Technology Transfer Seamless.

Technology Transfer is more than just a technical requirement. When it comes to driving progress and encouraging excellence in the ever-changing field of medical devices, intentional tech transfer and continuous hypercare is a strategic imperative. Our team at ECI can help ensure a smooth exchange of knowledge, expertise, and processes across every stage of your product’s lifecycle from conception to commercialization.

Technology Transfer with ECI

As global healthcare needs evolve and our clients work to deliver cutting-edge medical solutions, our dynamic approach to technology transfer helps you meet the unique regulatory demands that guide your work. This process serves as a crucial catalyst for innovation and efficiency in the field of medical devices, and is one of the most sought after solutions our team provides customers.

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Planning & Execution

To ensure successful technology transfer, it’s important first to assemble a multidisciplinary team of experts to oversee everything from equipment engineering, manufacturing, and process engineering to validation, quality, and regulatory support. Our team at ECI excels at putting the right people in the right places to help optimize resources and manage parallel projects effectively.

Create Initial Proposal For:

  • Budget
  • Timeline
  • Resources Needs
  • Regulatory Strategy

Develop Transfer Strategy

  • Staffing
  • Equipment & Instrument Calibration
  • Facilities
  • Materials – Supplier & Country Regulation
  • FinishGoods, BOMS, Routers
  • Process Quality Procedures
  • Validation
  • Regulatory
  • Packaging & Labeling
  • Remediation of Gaps

Technology & Knowledge Transfer

  • Finish Goods, BOMS, DWGs, Components
  • Process Docs (Routers,  Flow Charts, FMEA, WI)
  • Equipment, Tools & Manufacturing Aids (URS, DWGs, PMs, CAL)
  • Validation Doc (Protocols, TMs, FAIs)

Execute Validation

  • Materials
  • Equipment, Tools, Manufacturing Aids
  • Process
  • Clean Room
  • Sterilization
  • Packaging & Labeling
  • Regulatory Filing

Commercialize Product

After project completion, our team will work to ensure your quality engineers are properly read in and ready to take over processes with success.

Program / Project Management

From initial concept to final approval, let our experts help ensure your compliance initiatives are judiciously planned and effectively managed.

  • Domestic & International Support
  • Multi-Site and Multi-Divisional Solutions
  • Turnkey Approach

Manufacturing Transfer & Support

Manufacturing is a complex piece of the production process, and our team is ready to support you with every step of your upcoming transfer.

  • Manufacturing Technology Transfer & Line Set-Up
  • Master Validation Plan Development
  • Process Remediation and Improvement
  • Equipment Selection and Specification Requirement Definition
  • Process Characterization and Improvement

Research & Process Development

For greater efficiency, let our expert team support you with everything from product and process development to validation.

  • Technical Support
  • Product Design & Development
  • Process Design & Development
  • Design and Process Controls
  • Product Specification Development
  • Marketing Specification Development
  • Design Verification and Validation
  • Test Method Development and Validation
  • Packaging and Labeling Process and Product Development

Validation

We have a deep understanding of the standards your products must meet to successfully go to market, and we’re equipped to guide you through the intricacies of the validation process.

  • Product and Process
  • IQ/OQ/PQ Protocol Development and Execution
  • Equipment, Facilities, and Utilities
  • Computer System Validation (CSV)
  • Test Methods

Line & Product Development Engineering

Transfers & Product Development Engineering

We offer start-to-finish transfer and product development support to a variety of clients across the globe ensuring precision in processes while providing continuous hypercare support to their teams.

Process & Product Development Support

Our team offers consulting support for all process and product development activities including technology assessment, process characterization and process development for complex medical devices, design of experiments, tolerance analysis, and statistical models.

Manufacturing Processes

As you work toward ramping up manufacturing, our team provides support throughout each phase of hypercare. We’ll help your team define comprehensive instructions for your processes and create process flow diagrams for proper risk management documentation.

Development & Validation Documents

Lean on our validation cycle expertise for MVP, FMEAs, IQ, OQ, PQ/PPQ, CSV, and TM protocols. Through engineering studies that draw on complex statistical analysis, we’ll help support your internal teams.

Benefits of Tech Transfer Support with ECI

Our team can help you streamline tech transfers for greater efficiency and scalability. When you work with us, our multidisciplinary experts seamlessly integrate with your internal teams to identify pain points, find areas for improvement, and chart a strategic path forward. Our adaptability to diverse project requirements allows us to quickly learn the ins and outs of your processes and bolster the important work you do.

Plug & Play Transfer Model

Leveled Workloads

Seamless Integration with Your Teams

Quick Resolution for Workload Surges

Optimized Resource Utilization

Expert Management of Project Overlaps

Impact That’s Tangible

Why not see for yourself the value ECI provides to clients through technology transfer? Find insight on how we support customers through case studies specific to technology transfer.

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Post Market Surveillance & Vigilance Case Study

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Post Market Surveillance & Vigilance Case Study

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Post Market Surveillance & Vigilance Case Study

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Technology Transfer Case Study

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Technology Transfer Case Study

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Technology Transfer Case Study

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Our Strategic Services

Our team is here to expertly guide you through every product lifecycle challenge you may encounter. Learn more about our other service offerings through the link below.

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Let Us Help

You focus on your business. We focus on the momentum of the industry and help you keep pace across your portfolio.

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