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Biological Safety of Medical Devices

Präsenztraining2 TageBeginnerVirtuelles Klassenzimmer

Extend your knowledge about the biocompatibility of implants and medical devices!

In the demanding world of medical devices, biological safety is the focus. For products that come into direct or indirect contact with the body, it is critical to ensure the highest level of biocompatibility. This means that they must not cause rejection, toxic reactions, inflammation or other undesirable complications.

Documented evidence of biosafety is an essential step in meeting the Essential Safety and Performance Requirements of Annex I of the Medical Devices Regulation.

Our seminar offers you an in-depth introduction to the requirements of ISO 10993 (Part 1), as the international standard for the biological safety of medical devices. We not only guide you through the theoretical basics but extend your understanding by linking it to real-life practical examples. We will show you how ISO 10993 (Part 1) categorizes and classifies medical devices, as well as how to report in compliance with the standard and how to seamlessly integrate it into risk management according to EN ISO 14971. The inspections and tests that can be derived directly from ISO 10993 (Part 1) will be discussed in detail.

Our course relates this to and the current requirements of the revised ISO 10993 (Part 1) to the FDA Final Guidance "Use of International Standard ISO 10993, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a risk management process" (September 2023). We emphasize the critical importance of chemical/physical characterization as defined in ISO 10993-18 and address relevant sub-standards such as ISO 10993-12, -17 and -19.

Comprehensive explanations of international biocompatibility requirements and expectations of Notified Bodies round out the seminar. In our practice-oriented part, you will have the opportunity to exchange ideas with other experts and work through case studies together.

Take advantage of this opportunity to extend your expertise in biosafety.

This training is also offered in German, you can find the link here.

  • You will have a sound knowledge of the regulations on the biological safety of your medical devices.
  • You will acquire the know-how to create a biological evaluation programme and the recommended compatibility tests for implants and medical devices.
  • You will recognize the potential for reducing the testing burden in accordance with the ISO 10993 series of standards for the biological safety of medical devices.
  • Learn international differences in the application of the ISO 10993 series of standards, e.g. between the EU and the USA.
  • Regulatory Requirements according to MDR 2017/745
  • Requirements for biological safety according to DIN EN ISO 10993-1
  • Structure and content of the structured evaluation program
  • Necessary tests in the development phase of non-active medical devices
  • What should be considered in the literature search?
  • Testing strategy
  • International Requirements regarding Biological Safety
  • Content and structure of the biological evaluation plan and report
  • Practical workshop

Certificate of attendance from TÜV SÜD Academy

  • Responsible for the EC conformity assessment procedure and authorization.
  • Staff from development, quality assurance, clinical affairs, regulatory affairs
  • Product managers from the areas of manufacturing and distribution of medical devices
  • Representatives of authorities, decision-makers, consultants, lawyers
  • This seminar is part of a modular training programme. After successful participation in the advanced modules, you can obtain this recognized qualification:
  • #Safety Expert Non-Active Medical Devices - TÜV
  • The seminar deals with internationally valid standards and is also suitable for implementation abroad. The contents of the seminar correspond to the current status of revision/harmonization.
Nettopreis (exkl. USt.)
ab1.299,00 €

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Ab 24.10.2024
Online
1.299,00 € exkl. USt.

Veranstaltungsnr.
9642

Dauer
2 Tage

Seminarplan anzeigen

Veranstaltungsort
Online

Preis

Nettopreis
1.299,00 €
20% USt.
259,80 €

Bruttopreis
1.558,80 €
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