Common use of Systems Engineering Clause in Contracts

Systems Engineering. 1.1. Update design controls in compliance with JHU/APL’s Quality Management System and the FDA’s Quality System regulations 1.2. Conduct trade studies to evaluate currently-available commercial devices versus custom solutions for critical system components 1.3. Maintain requirements database 1.4. Maintain interface control documentation 1.5. Maintain risk management plan 1.6. Maintain test plan 1.7. Conduct periodic design reviews (with Second Sight)

Systems Engineering. 1.1. Update design controls in compliance with JHU/APL’s Quality Management System and the FDA’s Quality System regulations 1.2. Conduct trade studies to evaluate currently-available commercial devices versus custom solutions for critical system components 1.3. Maintain requirements database 1.4. Maintain interface control documentation 1.5. Maintain risk management plan 1.6. Maintain test plan 1.7. Conduct periodic design reviews (with Second Sight) 1.8. Provide support to Second Sight for clinical testing preparation