When lives are at stake, stringent processes and methods are necessary for the design and implementation of software for medical devices. Embedded software for medical devices poses unique concerns about safety and reliability, particularly with implantable devices. With extensive experience in life-critical systems, Esterline AVISTA has an absolute mandate for product quality and reliability for all medical applications development.
With over 20 years experience in critical systems, AVISTA offers expert program management and engineering staff, as well as considerable experience with FDA 510(k) certification. AVISTA’s verification experts can assist your company with the successful completion of your next product — and speed your time to market.
Providing the highest level of testing and validation. Medical electronics development requires that both the verification of the design and the software and validation of the finished device must be rigorously documented to the FDA 510(k) standard. AVISTA systematically applies specialized analyses, evaluations and testing of all software and its supporting documentation at every stage of the development process to assure that all the requirements have been fulfilled.