RTEmd offers a wide range of medical device testing, verification, and validation services to ensure that your software fulfills the stated requirements, complies with FDA regulations, and protects the safety of operators and patients.
We help manufacturers verify product design and test software at virtually every stage of the development lifecycle.
From analyzing requirements and developing comprehensive test plans to code reviews, testing, compliance audits, and documentation, we can help you navigate the FDA medical device approval process.
Committed to Accuracy from Start to Finish
Our skilled and highly qualified Quality Assurance department offers an end-to-end solution for your product testing needs, including:
- Requirements Management and Traceability throughout the project lifecycle
- Test Plan Development and Execution using industry-accepted automated tools, as well as customized manual solutions
- Test Case creation that's compliant with customer and regulatory requirements
- Quality Controlled Test Execution at the customer site or in our modern lab facilities
- Full Array of Auditing and Qualification services, including SAT, IQ/OQ/PQ, ISO 9001:2000, and Internal/External Corporate Auditing
- Software Process Improvement from Assessment and Recommendation to Design and Implementation of a Compliant Quality System
What Sets Us Apart
- We have a dedicated Testing Department. In a highly regulated environment, it's essential to have senior staff with specialized V&V expertise. We even provide training to our clients in state-of-the-art testing methodologies.
- Our staff has extensive FDA experience. Our seasoned team members bring years of experience working in heavily regulated FDA environments. They understand the Quality System Requirements (QSR), 21 CFR Part 820 Medical Devices, as well as Current Good Manufacturing Practices (cGMP).
- We bring deep clinical experience to every project. We have the skills and processes to conduct thorough tests of both software and medical devices. Plus, we have extensive experience in BL2 labs and hospital environments, including safe handling of bio-hazardous materials.
- We work efficiently in a variety of development environments. Our years of intensive involvement with Microsoft, Linux, Unix, and embedded environments give us the practical testing capabilities you need to succeed.
- We use automation to increase productivity and efficiency. With our automated test tools, we can reduce the testing timeline significantly. We provide full regression testing, enabling you to speed up your time to market.
Quality is a way of life at RTEmd
With our longstanding commitment to quality, we understand how to apply the strategies, tools, and processes used by quality leaders around the world. Whether your company has adopted TQM, Six Sigma, Lean Design for Six Sigma, or another disciplined methodology, you can count on us to make short work of the learning curve and consistently deliver outstanding results.
We look forward to speaking with you about our suite of verification and validation, testing, and compliance services. Contact us today.
