Digital health products are soaring high. Software is rapidly breaking down the walls between doctors, hospitals and patients. Meanwhile regulatory walls are being raised in Europe and lowered in the US. Without a doubt, the benefits of legislative controls for society are huge. But the regulatory labyrinth can be daunting to navigate for manufacturers, especially if software at the same time is subject to the medical device as well as the in-vitro diagnostic medical device or the pharmaceutical regulation.
During this webinar, COCIR helps you find your way through the regulatory maze and offers you a view from above. In four sessions, you will gain a solid understanding when and how European Medical Device and US FDA regulations apply to your software products, how to classify them, how to generate clinical evidence and how to keep your software secure.
The training will focus on every categorical software variation, whether it is a mobile phone application, software embedded on hardware, cloud computing service, neural networks for continuous learning applications, software as part of a combination product or plugins that run on consumer electronics or platforms in the Internet of Things.
Speakers are both theoretically knowledgeable on, and frequently
practically engaged in, the creation of European and FDA guidance
papers. This enables them to provide you with the latest authoritative
insights on upcoming legislation and interpretative guidance
documents. Participating companies with a marked interest in the
interlinkage between medical devices and in-vitro devices as well as
pharmaceutical regulation will thus discover that there is more than
one way to fly above the legislative tides.
The programme can be found here
In you're interested to attend, online registration can be done here