Full Spectrum is a full-responsibility medical device development company. With more than 40 years experience bringing life-changing products to market.
Our cross-functional teams have partnered with clients to successfully deliver hundreds of cutting-edge software-based products to market. Our Technology Consulting and Systems Engineering services are designed to bring clarity to key products, technology or process issues in weeks, not months.
Our Product Development and Verification services have enabled Full Spectrum to partner with clients in the delivery of hundreds of products in nearly every corner of the MedTech and Digital Health industries.
Full Spectrum is a full-responsibility medical device development company. With more than 40 years experience bringing life-changing products to market.
Our cross-functional teams have partnered with clients to successfully deliver hundreds of cutting-edge software-based products to market. Our Technology Consulting and Systems Engineering services are designed to bring clarity to key products, technology or process issues in weeks, not months.
Our Product Development and Verification services have enabled Full Spectrum to partner with clients in the delivery of hundreds of products in nearly every corner of the MedTech and Digital Health industries.
DRIVING SUCCESSOur Value Proposition for You and Your Business
From initial concept to development, prototyping to implementation, V&V to commercialization
Key contributors to the initial 62304 Software Lifecycle Process Standard, TIR32 on Medical Device Software Risk Management, and TIR36 on Automated Process Software Validation.
Recognized and sought out for our experience and proficiency around 62304, 62366, 14971 and V&V Strategy.
Our proven approach to program discovery, definition, and planning ensures a smoother more predictable journey — from concept to commercialization.
With nearly 40-years of experience and a thousand medical devices under our belt, we’ve helped clients optimize efficiencies and accelerate their time to market.
OUR APPROACHEngagement 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 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.
