About the Event

Join us to explore the intricacies of medical device development and its essential components

Genesys Electronics Design will present the Device Development model, focusing on the Waterfall model in accordance with FDA's Design Control Guidance. This session will delve into critical areas and necessary steps, emphasising the significance of various standards including:

• QMS (ISO 13485)
• Electrical Safety (IEC 60601-1)
• and Software Lifecycle Processes (IEC 62304)
• and other relevant standards.

Followered by a diverse panel to address all your questions regarding medical device development and manufacturing.

Where: Flinders University City Campus

When: Registrations open 9am with light refreshments

For product developers that need absolute reliability in their products, with a well managed, cost-controlled pathway to commercialisation, Genesys is a specialist developer of products with electronics and software, complete with mobile apps, backend systems and aesthetic human-centered enclosures.

Genesys has 20 specialist engineers delivering the full stack of capability and backed up by 30 years of experience and ISO 13485 quality assurance systems.

For those who would like to book a 1:1 meeting with Genesys in the afternoon, please use this link: https://calendar.app.google/aCvLVuhN6Vsaybq68

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