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
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:
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.