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Methodical Development

 

LRE’s Product Development processes provide a structured but adaptable process that transform ideas into specifications and ultimately into manufactured in vitro diagnostic (IVD) devices that meet the requirements of DIN EN ISO 13485:2009 and FDA CFR Part 820.

LRE’s IHK Certified Program Managers along with their Dedicated Project Teams ensure that the correct technical tasks get done during development through planning, tracking, and coordinating. Responsibilities of LRE’s Program Managers include:

  • Development of a total system design solution that balances cost, schedule, performance, and risk,
  • Verification that technical solutions meet or exceed customer requirements,
  • Development of a system that can be produced economically and supported throughout the product’s life cycle.

LRE’s System Engineering staff integrates the different engineering disciplines to create optimized product solutions. A group of physicists is dedicated to design and to control interdisciplinary functions such as:

  • Tolerance calculations and error budget allocations
  • Detailed performance fractioning
  • Thermal behavior
  • Artifact suppression and digital signal improvements
  • Calibration principles
  • Overall performance testing

 

Managing LRE’s product development efforts is accomplished by integrating three major activities:

  • A V-model based Product Development process that provides a structure for solving design problems and tracking requirements flow through the design effort,
  • Development phasing that controls the design process and provides baselines that coordinate design efforts, and
  • Life cycle integration that involves LRE’s OEM customers as well as their customers in the design process and ensures that the system developed is viable throughout its life.

The following are expected outcomes of these processes:

  • Customer Focus and Improvement of Communication
  • Conformance to Customer Expectations
  • Conformance to Product Specifications
  • Fact Based Decision Making
  • Minimization of Project Risks
  • Improvement and Guarantee of Quality
  • Reduction of Total Cost and Time
  • Continuous Improvements

  

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