High quality and reliability

Time to market

Comply with Codes of Federal Regulation

Comply with "In vitro medical device" Directive

Technical files complying with FDA 510(K) and CE Mark requirements

Open system

Feasibility and validation by the Customer

Mechanical

Electronic

Hardware

Chemistry

Software

Sub System Development Plan

System requirements

System Risk Analysis

SW risk analysis

System Validation Plan (based on Risk Analysis)

System Change Control Plan

System Problem Management
(based on web-shared database)

Project Plan

Development Management

Quality

Configuration

Design Review

Audit

Requirements

Functional (features, performance)

Non functional (security, safety, reliability, etc.)

Risk Analisys Management

Verification Plan and Protocols

Iterative controls through lifecycle

Reports

Traceability

Change Management / PLE
(Product Line Engineering)

Change / enhancements / defects

Controlled SW Development Process

Requirement definitions (SRS with Requirement ID)

Design

Testing (Test Case, Summary, Report, Coverage Matrix)

Integration

Release

Installation

Release Notes

Qualification test

Acceptance test

Maintenance / PLE

Corrective actions

Improvements