SDMD Global in Berlín

On a two-days conference format and 100 attendances, the event covers some of the most significant and concerning topics in Medical Devices development: EN62304, FDA regulation, and cybersecurity.

Our SW experts Daniel Bujalance and Martí Cobos, presented our experience on image algorithm development through Mathworks, one of the successful projects developed in Idneo Technologies.

To sum up,

• Medical Device manufacturers are very focused on regulatory affairs. MDD to MDR & IVD to IVR transition are to be big challenges.
• Security in Medical Devices has become critical. Risk management must be considered.
• Agile development for medical devices is fully compatible with FDA or EN62304 SW life cycle if applied in the correct way.
• Machine learning & Deep learning is already here, however there is no regulation at all for Medical Devices.

Thanks Dani and Marti for your participation!