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+600 Corsi di formazione +130.000 Partecipanti all'anno in tutto il mondo Docenti esperti e qualificati
Certificati accreditati e riconosciuti a livello internazionale
+39 051 2987 411
Event Scheduled: On request Learning Mode: Online Language: English (see more details below)
Introduction
The assessment of the biocompatibility of a medical device is essential for the identification, evaluation and management of the biological risk of a medical device. The course is aimed to medical device manufacturers, regulatory professionals, project managers and consultants involved in the biological evaluation of a medical device.
This course will provide an overview of the complex issues surrounding the biological evaluation of medical devices, including general principles governing biological evaluation, categorization of medical devices, evaluation, additional data, risk assessment and interpretation of the biological tests followed by gap analysis for the medical devices based on categorization, and the General Safety and Performance Requirements of the MDR related to biological safety. The expectations of a Notified Body about the biocompatibility assessment will also be discussed.
Learning Objectives
Understanding the regulatory requirements concerning the biocompatibility of medical devices according to the State of the art (SOTA)
Body contact and biological effects for consideration and biological effects for evaluation..
GSPR
Overview of the NB perspective for the biological evaluation.
Who will benefit?
Medical Devices manufacturers, RA professionals, project managers and consultants.
Course Agenda
Regulatory overview
Applicable standards overview - SOTA
ISO 10993-1:2025: risk assessment, categorization of devices, and key points
GSPR
NB perspective for the biological evaluation
Q&A
Prerequisites
Basic knowledge of the ISO 10993 standard series (SOTA or Harmonized)
Knowledge of EU regulation 745/2017 (MDR)
Learning Assessments
Upon completion, you will receive your globally recognised TÜV SÜD certificate of attendance on Introduction to Biocompatibility basics for medical devices.
Teaching Materials
Handout, containing the slides projected during the course, in case of online courses it will be provided in electronic format;
Notebook for didactic use (where applicable), containing a copy of the standards necessary for the training course, to be returned at the end of the course. In order to respect copyright, all the standards of online courses can be provided for consultation only through access to a dedicated portal. For a higher quality of teaching and preparation for exams (where applicable) it is advisable that participants purchase the reference standard directly from the official ISO store https://www.iso.org/home.html or request a copy within their own organisation.
Duration
8 hours.
Scheduled Events
Events will be planned on request (and published on this page).
