Is my software a medical device? How to step forward?

10 April 2024 | 4 – 5 pm (CET) | Webinar

In this SPARK Europe Webinar, Heikki Pitkänen will discuss the regulatory landscape of medical software solutions.

During this talk, you will hear about:

• what are the rules and challenges with defining which regulations (the MDR or the IVDR) apply to your developed software
• what are the grounds for classifying software into Class IIa or higher, exposing them to Notified Body assessment, or in Class I in remote cases
• comparison to the US FDA and what the regulations mean in practice for medical device software developers, not forgetting AI

For the knowledge transfer, Heikki will use their proprietary regtech platform Entries to explain some of the above principles.

Heikki Pitkänen has over two decades of experience in medical device development. He is the CEO and founder of Lean Entries Ltd., a group of regulatory experts in global medical device regulations providing unique digital regulatory services as well as traditional consulting for the MedTech sector from academies and startups to multinational enterprises.

The event is hosted by SPARK Finland.

Please register here!

Registration to the webinar is required in advance. Please register by 9 April 2024.