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<h3>Want more info?</h3>

We get it: you need a superior software solution, but don’t know where to begin. Download this handy PDF by clicking the link below, and we’ll guide you through our process and showcase other clients that have had amazing successes.

<h5 style=”color: #444444;”>Have more questions?</h5>

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<span style=”color: #b2dd4c; line-height: 20px; font-weight: 700;”><a href=”mailto:info@fullspectrumsoftware.com”>info@fullspectrumsoftware.com</a></span><br />

<span style=”color: #b2dd4c; line-height: 20px; font-weight: 700;”><a href=”tel:+1+15086206400″>+1 (508) 620-6400<a/></span>

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Software Development Life Cycle

From our first contact, Full Spectrum Software is here to support you and your team. Over the past 23 years, we’ve helped our clients with Compliance, Design, Development, and Testing to deliver a wide range of Medical and Life Science products to market. Employing Agile, Waterfall, or a hybrid methodology, we can work as an independent outsourced team or a tightly integrated extension of your own team.

Our Process

Our 13485:2016 compliant Quality Management System meets our most demanding clients as well as being flexible enough to meet the needs of our clients who have fewer regulatory requirements. We can find a solution that provides the most value for your timeline and budget.

Planning

Activities

Needs Analysis

Research

Stakeholder Interviews

User Interviews

Competitive Analysis

Roadmap Analysis

Deliverables

Project Plan

Project Schedule

Personnel Requirements

Milestone Definition

Software Development Plan

Transparency

Stakeholder Interviews

Roadmap for Software aligned with business needs

Project-Management---Gantt-Chart

Requirements, Definitions & Analysis

Activities

Competitive Analysis

User Interviews

Regulatory Requirements

Determine Level of Concern/Software Safety Classification

Deliverables

Detailed Software Requirements Specification

Use Cases

Transparency

Review and approval of all specifications

Activities

Risk Analysis

Human Factors

Deliverables

Risk Analysis and Risk Management Report

Human Factors Engineering Report

Transparency

Software Risk Analysis and Human Factors in context of system as whole

Design

Activities

Software Architecture

Software Component Design

Wire-framing

User Testing

Proof of Concept

Verification Test Planning

Deliverables

System Architecture Document

Requirements Traceability Matrix

Design Specification

UI Prototype

Functional Specification

Verification Testing Plan

Transparency

Review and approval of UI Prototype

Review and approval of all specifications

Development

Software Development & Testing

Component implementation with unit testing

Agile approach with daily stand up

Interim builds for SQA testing

Test Protocol Authoring

Requirements Traceability Matrix development

Defect Tracking

Transparency

Customer welcome to any and all stand up meetings

Defect triage

Interim milestone review

Weekly reporting of progress and issues

Agile-PMP-on-Clear-Board

Verification & Validation

Activities

Execution of Verification Test Protocols

Deliverables

Records of Protocol Execution

Software Released to Customer

Software Verification Test Report

Completed Requirements Traceability Matrix

Final Product

Activities

Compilation of Design History File Materials

Deliverables

Project Binder

Software Ready for Release to Customer

Product-Star-Chart

Want to Know Our Full Development Process?

Ready to Get Started?

Let’s Build You The Perfect Software Solution

Boston Scientific – Square

Waters Inc – Square

Xagenic – Square

Applied Biosystems – Square

ThermoFisher – Square

Osprey Medical – Square

Radiadyne – Square

Nabsys – Square

Medtronic – Square

Covidien – Square

Abbott – Square

Toshiba – Square

Amazon Robotics – Square

Hospira – Square