About Us

About Us

Our Value Proposition for You and Your Business

End-to-End Product Lifecycle Support
From initial concept to development, prototyping to implementation, V&V to commercialization

 

Exceptional Regulated Product Development Expertise
Key contributors to the initial 62304 Software Lifecycle Process Standard, TIR32 on Medical Device Software Risk Management, and TIR36 on Automated Process Software Validation

 

Masterful Compliance Consulting
Recognized and sought out for our experience and proficiency around 62304, 62366, 14971 and V&V Strategy

 

Predictable Product Outcomes
Our proven approach to program discovery, definition, and planning ensures a smoother more predictable journey — from concept to commercialization

 

Accelerated Time To Market
With nearly 40-years of experience and a thousand medical devices under our belt, we’ve helped customers optimize efficiencies and accelerate their time to market

Engagement Models

 

Full Spectrum takes a practical approach to structuring engagements based on the unique characteristics of our clients and their needs.  Our first goal is to gain an understanding of our client’s needs and goals so we can use that input to recommend starting points, phases, and engagement model.  

 

Full Spectrum’s engagement models are as follows:

  • Full Program Responsibility 
    Full Spectrum is managing a complete product/system program or a significant aspect of the product/system including technical and project lead requirements, architecture, design, implementation, verification, documentation, and compliance.​​
  • Custom Engagement​
    Based on a client’s specific need, Full Spectrum will design an approach that best aligns our capabilities with our client’s goals to maximize value.  This takes into account the client’s organizational structure as well as what we collectively feel will be most effective and efficient.

Intertech Engineering Associates. A most welcome addition.

Renowned industry leaders in medical device design, development, verification, validation and training, Intertech Engineering Associates has joined forces with Full Spectrum. Together, our combined teams have played an integral role in the advancement of hundreds of medical technology breakthroughs.

 

Leadership Team

Learn more about our leadership team with decades of experience in the Life Sciences and Medical Device industries. Under their guidance, Full Spectrum is focused on developing the most advanced and cutting-edge products that impact our lives in many ways.

Ready to Get Started?

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