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 |