SOFTWARE AS A
TEST & RELEASE
Defining use cases early in the process is critical to correct functionality and user acceptance of your digital health or medical device app. We meet with you and your stakeholders to specify all potential users and use environments. Early focus on how patients, physicians, and caregivers will use your app drives creation of clear-cut requirements, rich UI/UX design, and ultimately on-target app development.
Taking the requirements and other design inputs from the DEFINE stage, we employ an IEC 62304-compliant agile software development process to deliver versions of your medical app early and often. Gaining feedback from users throughout the entire development process is critical to success. We work with your project management team to line up our iterative process with your high level project milestones and deliverables.
FDA-regulated Software as a Medical Device (SaMD) must go through a detailed design verification and validation test process. Our team is highly skilled at writing formal test plans, executing, and generating reports that integrate seamlessly with your DHF for regulatory success. We will also work with your team and manufacturers to help define the most appropriate release management strategy for your medical device app.
GET TO KNOW US
EDWARD J. PALMER
Edward received his bachelor of science in Electrical Engineering from the University of Minnesota, Twin Cities. With almost 20 years of medical device product development experience, Edward brings a strong background of successful electrical and software engineering, project management, and leadership prowess to any project.
Edward wears many hats as the leader of the Palmer Wireless Medtech team. He's not your prototypical engineer...he's production ready!
App Development Firm XYZ might be "the best in town", but do you trust them to know the intricacies of medical device software development?
Our years of medical product development experience makes us the preeminent choice for high-quality FDA and HIPAA-compliant software and documentation that fits into your DHF perfectly.
Our vision is to improve the quality of life for patients, along with improving the satisfaction of caregivers and physicians who interact with medical device apps, while making the development process pleasurable and hassle-free for device manufacturers like you.
Medical device app development is only as good as the tools and the people using those tools. We use industry-leading cross-platform native development technology in order to deliver a uniform output and experience regardless of the deployment platform.
Cross-platform native development technology avoids the burdensome costs of managing multiple code bases for different deployment platforms and allows for a single set of design documents to exist for your DHF.