Introducing and implementing quality management for (AI-based) medical devices (Online)

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Online Participation: VDE Members only 630,00 € Online Participation (Non-Member) 690,00 € Free Booking by Organizer

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Description

The quality management system (QMS) of medical device manufacturers and AI system providers serves as basis for compliance with legal provisions and, moreover, enables the organization to produce safe and reliable products for the benefit of patients and commercial success. The relevant European legislation MDR and AI Act contain concrete requirements that are at least partially fulfilled by the application of the standards EN ISO 13485 and ISO/IEC 42001, respectively.

In this event, the realization of the project “introduction of a quality management system” will be illustrated using a fictitious model organization. We will address both the QMS requirements for medical devices and high-risk AI systems. The theoretical basics will be supplemented by practical examples from the professional experience of Dr Thorsten Prinz (VDE).

The event format offers sufficient time for your questions and discussions.

The presentations will be given in German. You will receive all presentation files and example documents as PDF (in English).

We are looking forward to your participation!

Agenda

08:55	Registration
09:00	Welcome and introduction Thorsten Prinz, VDE
09:15	Introduction to quality management for medical devices Motivation, purpose and stakeholders of quality management system (QMS) Life-cycle approach and quality philosophy Overview of QMS requirements in MDR, AI Act, EN ISO 13485, and ISO/IEC 42001 Specific as aspects for manufacturers of AI-based medical devices Integration of quality management systems with different scope
10:45	Coffee break
11:00	Project "Introduction of a quality management system": Start and implementation Introducing a fictitious model organization Process identification and visualization Quality manual, politics, and objectives as QMS basis QMS organization: process and document control, roles and responsibilities Example process descriptions and template documents Process measurements and internal audits Challenges and pitfalls
12:30	Lunch break
13:15	Project "Introduction of a quality management system": Certification and maintenance/improvement Role of the Notified Body in the certification process Certification audit and audit deviations Differences of EU QMS (MDR) and EN ISO 13485 certificates Market phase: measurement, analysis, and improvement of QMS Re-Certification audit and substantial changes to QMS
14:45	Discussion
15:15	End of event

Preliminary program. Subject to changes / adjustments

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The event is organized for at least 3 participants. If the minimum number of participants is not reached one week before the start of the event, we reserve the right to cancel it. For organizational reasons, registration for our events usually closes 3 days before the event date. Thank you for your understanding.

Cancellations can only be made in text form and are possible up to 8 days before the event date. In this case, a cancellation fee of 25% of the ticket price will be charged and retained when the amount paid is refunded.

This means that 100% of the ticket price will be due in the event of a short-notice cancellation of 7 days or less.

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