The last decade has seen rapid growth in advances to computer technology/systems and software development. Accessibility to smartphones and other handheld devices has changed the medical device space drastically, manufacturers can now provide the end user be that the patient, healthcare professional or technical expert, with a device which has the capability to support clinical decisions, control other medical devices, generate and process data as well as so many other options. The development of apps can turn any smartphone or handheld device into a tool to be used as a medical device.
With these rapid advancements, the regulatory landscape has become increasingly complex. KD&A is here to guide you through the regulatory maze, ensuring that your SaMD meets all necessary requirements and is market-ready.
Contact us today for a tailored consultation and custom quote.
Have a few questions? Visit our Frequently Asked Questions page.
KD&A can assist you to most effectively demonstrate compliance with Australian (TGA) and/or European requirements