Overview
Business Opportunity
Research/Planning
Conceptual Development
Implementation
Support

Quality Engineering Services

Stratos sees Quality Engineering as essential to the success of new product development, from initial requirements specification to verification and transfer to manufacturing.

Quality Engineering ensures that the design process and resulting project deliverables are compliant with the client's regulatory environment. We have developed internal quality processes to ensure that a medical device design will be capable of meeting a client's FDA or EU Directive regulatory needs.

Quality Engineers also accurately translate safety agency standards into product requirements to ensure that the design will qualify for UL or any other safety agency certification.

Expertise In
Quality System Requirements
Regulatory Compliance
Safety Standards
Product Specification
HW & SW Verification
Risk Management / Risk Analysis
Essential Performance
Safety Agency Certification
Process Validation
Supplier Qualification
Transfer to Manufacturing
Overview
Project Management
Product Planning
Industrial Design
Mechanical Design
Electrical Design
Software Design
Optical Design
Quality Engineering
Strategic Manufacturing