When Success is the Only Option
For more than three decades, Genuen's core focus has been supporting the successful execution of complex projects in regulated industries. Benefit from our extensive experience of providing flexible, timely and cost-effective solutions that leverage reuse of common test architecture and infrastructure throughout the product life-cycle. Our approach helps you to establish a competitive advantage by optimizing value from your investment in test, decreasing overall development costs and reducing time-to-market.
Safety and Mission-Critical Expertise
Partner with Genuen to help ensure success. Our engagement objectives include lowering risk, improving processes and accelerating the development of your next challenging project.
Leverage Our Extensive Working Knowledge of Regulatory Guidelines and Related Processes
- Aerospace DO-178C, DO-254, DO-160, DO-330
- Automotive ISO 26262
- Rail EN-5128, EN-5129
- Medical IEC 62304, 21 CFR 820
Document Your Development Process Through Formal Project Planning
- Development Plans
- Verification Plans
- Configuration Management Plans
- Software Quality Assurance Plans
- Accomplishment Summaries
- Safety Manuals
Achieve Successful Compliance with Regulatory Guidelines with Our Project Execution Solutions
- Requirements Review
- Gap Analysis
- Requirements Generation
- Project Documentation
- Design for Requirements-Based Testing (RBT)
- Scalable, Automated Test Solutions
- Data Collection, Monitoring, and Analysis
Software Tool Validation of OTS Medical Software
Genuen created a tool qualification kit (TQK) for IBM's DOORS Next Generation (DNG) product, which is a commercial software solution used for requirements management. In this case study DNG was being used in medical device software product development. Stringent medical device standards like 21 CFR 820.70(i) and 21 CFR 11 require that software tools used to develop medical devices be validated. Learn more about Genuen’s TQK and how it helps to streamline the software tool validation process to meet the rigorous requirements of 21 CFR 820.70(i) and 21 CFR 11.
Safety and Mission-Critical Solution Benefits
Receive Expert Guidance in Standards Compliance
Create Documentation to Support Regulatory Requirements
Streamline Design with Platform-Based Test Systems and Software
Achieve Flexible, Timely, Cost-Effective Product Development
Successfully Execute Complex Projects
Translating Experience from Aerospace to Other Industries
Learn how Genuen's experience in the development of test infrastructure to meet strict standards such as DO-178 translates to standards and compliance testing in other industries. The expertise of compliance lies in understanding the applicable process objectives; and in setting the project up for success in each phase through careful planning, execution, and attention to detail.
TOOL QUALIFICATION KITS
Many regulatory agencies require that software tools used to tailor the safety life-cycle must be qualified to ensure that the tool is functioning correctly for the intended purpose. Genuen’s Tool Qualification Kits (TQK) provide a solid foundation for achieving formal qualifications used as part of your development process in highly regulated industries such as automotive, aerospace and medical devices.
Looking for Solutions for Your Safety and Mission-Critical Applications?
Contact our team for a free consultation.