Medical Device Certification

Mobile health devices make it possible for clinicians to monitor patients’ health on a day-to-day basis, regardless of their physical location. These technologies can greatly improve care for patients who are not well-served by the traditional healthcare system.  Healthcare providers do, however, need to consider regulatory and privacy concerns as they adopt mobile health devices.

KI Design offers niche market specialization in risk management tools and solutions, and is dedicated to advancing technology by providing medical device security advisory based on recommendations from the U.S. Food and Drug Administration (FDA). We provide advice on standards that help support medical-device interoperability and cyber security. Our consultants are members of IEEE, which delivers a suite of standards for medical-device communication.

We can:

  • Help healthcare product vendors and integrators create interoperable and secure devices and systems
  • Help healthcare providers procure secure devices for disease management, health and fitness, and independent living that can help save lives and improve quality of life
  • Provide advisory on enabling interoperable communication for traditional medical devices, as well as personal health devices
  • Provide recommendations on risk-management standards
  • Ensure application of interoperability standards & cyber-security standards
  • Assist manufacturers electing to declare conformity with consensus standards to meet specific requirements for the creation of medical devices