As medical devices become more complex, so does the software and the test automation that is expected to reduce failures and bring the product to market without delay. Understand the regulatory guidance, standards, and best practices can be daunting to get it all right. Test life cycle management is critical to getting the software components working together with various test methodologies available. Software quality assurance teams that have good alignment with the standards, are in sync with the software development process, timely feedback, continuous test, and excellent feature coverage are positioned for success. Verification and Validation approaches with test automation are discussed to give the attendee the knowledge with respect the landscape of the medical device domain.