Cover Image for From Code to Compliance in MedTech: Can AI Close the Gap Between Development and Regulatory?
Cover Image for From Code to Compliance in MedTech: Can AI Close the Gap Between Development and Regulatory?

From Code to Compliance in MedTech: Can AI Close the Gap Between Development and Regulatory?

Hosted by Julia Hermann & Lara Hanyaloglu
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About Event

​CertHub × Revolve Healthcare | Business Breakfast

​Join us over breakfast to discuss where AI can help with the practical challenges of developing medical software and meeting regulatory requirements. Bring your questions and exchange ideas with fellow MedTech professionals.

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​What can you expect?

​A small roundtable focused on practical challenges in MedTech.

​Revolve Healthcare and CertHub are bringing together MedTech leaders and innovators to share experiences, ask questions and hear perspectives from others working within the industry.

​What we’ll discuss

​The discussion will bring together CertHub’s regulatory expertise and Revolve Healthcare’s experience in medical software development. With Luca Salvatore, International Regulatory Affairs Expert at CertHub, guiding the conversation, we’ll explore:

  • ​Where AI could support technical documentation and quality management in practice.

  • ​How development and RA/QM teams can keep requirements, software changes and documentation connected.

  • ​The challenges of working with software as a medical device (SaMD) and software in medical devices (SiMD).

  • ​What teams need to trust, review and use AI-generated outputs.

​Please feel free to bring your questions and share experiences as they will help shape the conversation.

​Meet your hosts

​Revolve Healthcare
An ISO 13485-certified medical software development company, helping MedTech teams design and develop medical software and healthcare applications.

​CertHub
An AI-powered MedTech compliance platform that helps manufacturers create, manage and maintain technical documentation and quality management systems.

​Join us around the table

​Start your MEDICA day with a complimentary breakfast, coffee and a conversation with fellow MedTech professionals.

Location
Café Emanuel
Stockumer Kirchstraße 7, 40474 Düsseldorf, Germany