Basic-course: AI-BASED MEDICAL DEVICES and IVD: Navigating FDA Regulations

AI-driven innovation is transforming U.S. healthcare—from diagnostics to personalized medicine. But with this progress come high regulatory expectations. The FDA’s latest guidances outline clear pathways for managing AI across the product lifecycle, including how to implement algorithm changes using Predetermined Change Control Plans (PCCP).

Learn how to get a global overview of AI-related requirements in the US regulatory landscape for medical devices and IVDs. You will gain practical skills to assess technical documentation, ensuring both compliance and successful market access of AI-powered health technologies.

Participants:

Regulatory Affairs Manager, Quality Management Specialist / QMS Manager, Legal Compliance Officer, Product Manager – Medical Devices / IVD, R&D Manager – AI-Based Medical Technologies, Post-Market Surveillance (PMS) Specialist, Clinical & Regulatory Strategist, Risk Management Specialist, Software as a Medical Device (SaMD) Expert, Internal or External Auditor – MDR, IVDR, ISO 13485

This basic course is part of our online course: DEVELOPING AI-BASED MEDICAL DEVICES AND IVD IN COMPLIANCE WITH REGULATIONS.

Seminar contents:

Regulations for AI-based Medical Devices and IVD in USA

• Overview of the most important concepts and terms in AI
• Regulations in USA
  • FDA Guidance on AI-Enabled Medical Devices
  • ISO 13485 – Quality management systems for medical devicessystems — Requirements for regulatory purposes
  • IEC 62304 – Software life cycle processes for medical device software
• Exercise:
  • The participants receive a fictitious AI product and work out which FDA requirements must be met. They create a checklist of the necessary documents (e.g. risk assessment, validation data, Predetermined Change Control Plan).

Your Trainer

DI Martin Schmid, Managing Director & Senior Consultant, en.co.tec Schmid KG

Costs:

• Early bird (until 4 weeks before the seminar): Euro 260,- (excl. VAT)
• Standard (starting 4 before the seminar): Euro 305,- (excl. VAT)
• incl. seminar documentation as PDF and certificate of participation
• All seminar discounts at a glance

EVENT LOCATION: LIVE-ONLINE!

You will receive the course documents and a link to the virtual seminar room via email in a timely manner. Each module is designed to be interactive, similar to a face-to-face seminar. You can ask the lecturer questions, complete exercises, and exchange ideas with the other participants.

Click here to book now!

For questions: office@encotec.at or +43 1 8863491