Das Online-Seminar findet in 8 Monaten, am 12.06.2024 von 09:00 – 13:00 Uhr statt.

Biological Evaluation of Medical Devices II

Chemical and physical characterizations are the first step in the biological evaluation of medical devices. Our industry-experienced expert Dr. Loos will introduce you to the normative and regulatory requirements for products already on the market and new approvals, taking the MDR into account. You will receive an overview of concepts and requirements of parts 17, 18 and 19 of the ISO 10993 series in the context of the biological evaluation of medical devices. A particular focus is on the identification and evaluation of critical ingredients (e.g. phthalates) or residues including particles and degradation products.

Zielgruppe und Vorkenntnisse

Participants with previous knowledge of biological assessment (at least biological assessment I)

Inhalte

  • Role of chemical and physical analysis in biological risk assessment and relevant standards
  • Conceptual approach to physical characterization according to ISO TS 10993-19:2020
  • Chemical characterization according to ISO 10993-18:2020 and its limitations
  • Evaluation of the results of chemical characterization (ISO 10993-17:2023/ TTC concept)
  • Concepts for evaluating CMR
  • Evaluation of particulate residues

Ermäßigungen

Participant discount: From the 2nd participant you will receive a discount of 15% on the net price.

Customer discount: mdc customers receive a 10% discount on the net price.

Hinweise

Participant and customer discounts cannot be combined! The discount will be deducted automatically if a booking concerns employees of the same company and the same seminar.

Please note that the registration fee and the associated participation only applies to one person. If several people take part in the remote-seminar, although only one person has registered, we reserve the right to exclude the further persons from the seminar.

Preis pro Teilnehmer

450.00 Euro (zzgl. ges. MwSt)