Engineering

 

Our engineering services are tailored to help you bring cutting-edge products to the market efficiently and effectively. With a team of seasoned engineers and industry experts, we provide comprehensive solutions that drive progress and ensure compliance at every stage.

Our Engineering Services include:

 

Commissioning, Qualification, and Validation (CQV)

Our comprehensive CQV approach ensures that your systems, equipment, and processes are compliant, efficient, and reliable, reducing risks and ensuring high-quality outcomes. Our CQV services include:

  • Functional testing
  • Equipment Installation and Verification
  • IQ/OQ/PQ activities
  • Process Validation
  • Method Validation
  • Computer System Validation

Automation and Control

Stay ahead of the curve with our state-of-the-art automation solutions. We integrate advanced control systems to streamline operations, enhance data accuracy, and boost productivity. Our services cover:

  • Control System Design and Implementation
  • SCADA and PLC Programming
  • Data Acquisition and Analysis
  • Automation Validation and Compliance

Process Engineering

Optimize your processes with our advanced engineering solutions. We specialize in designing, implementing, and optimizing manufacturing processes to improve efficiency, reduce costs, and enhance product quality. Our services include:

  • Process Design and Optimization
  • Scale-Up and Technology Transfer
  • Process Validation and Qualification
  • Continuous Improvement Strategies

Facility Engineering

Build and maintain world-class facilities with our expert guidance. We provide end-to-end support for facility design, construction, and maintenance to ensure your operations run smoothly and meet regulatory requirements. Our offerings include:

  • Facility Design and Layout
  • HVAC and Cleanroom Solutions
  • Utilities and Systems Integration
  • Facility Commissioning and Validation

Design Engineering

Our expert team combines deep technical knowledge with a thorough understanding of regulatory requirements to help you conceptualize, develop, and commercialize innovative products that transform healthcare and life sciences. This includes:

  • Feasibility Studies
  • Design & Development
  • Product Risk Analysis
  • Design Verification & Validation

Software Engineering

Our dedicated team of software engineers combines technical expertise and agile methodology with a deep understanding of regulatory requirements to deliver robust, scalable, and compliant software solutions that drive innovation, including:

  • Custom software development and integration
  • Software Verification and Validation
  • Computer System Validation (CSV)
  • Software as a Medical Device (SaMD) development
  • Software system architecture and requirements analysis

Partner with EMMA International for engineering services that set the standard in the life sciences industry. Contact us today to learn how we can support your projects and help you achieve your goals.

Ready to learn more about working with us?

Engineering Resources

De Novo Classification

De Novo Classification

A device can be registered for the De Novo pathway if there is evidence of the safety and effectiveness of the ...
Abbreviated 510k submission

Abbreviated 510k submission

There are three types of 510K, Premarket Notifications, which can be submitted to the Food and Drug Administration ...

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