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. 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.

Our 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.

 

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.

 

• PAT BAIRD                   Regulatory Head of Global Software Standards at Philips
• KOEN COBBAERT         Chair of COCIR’s Software Task Force, Agfa HealthCare
• TIBOR DULISKOVICH    Physician, Medical Director at GE HealthCare
• ZUZANNA KWADE        Medical Affairs Manager at Agfa HealthCare
• BEN KOKX                   COCIR Lead Member on cybersecurity, Director Product Security at Philips
• TOBIAS SCHREIEGG      Vice-Chair of COCIR’s Software Task Force, Siemens Healthineers

 

Download the programme here

 

 

Limited availability