Biological evaluation of medical devices in accordance with EN ISO 10993-1
Overview
Objectives I Skills and Abilities
Understand the methodology of biological assessment in accordance with EN ISO 10993-1
Assess the conformity of a biological assessment plan
Programme
Part 1 - Context of the standard in European regulations
Part 2 - The fundamental principles of the ISO 10993 series
Part 3 - Biological assessment using the methodology of EN ISO 13993-1
Part 4 - Case study to conclude on the conformity of the proposed biological assessment plan
Part 5 - Evaluation by questionnaire
Methods used
The course is based around a presentation containing case studies, role-playing exercises and ongoing interaction with the expert. Trainees will receive a handout. A final quiz will validate what has been learnt.
To enhance online learning, our courses are run in small groups, from a minimum of three people to a maximum of 6. Our courses are delivered through synchronous learning.
Public
Audience
DM players. Quality managers. Functions responsible for compiling technical documentation.
Prerequisites
Knowledge of medical device risk classes, the EU certification process as presented in Regulation 2017/745.
General knowledge of issues relating to the biocompatibility of healthcare products.
Paul Fernandes
Biocompatibility toxicologist
La certification qualité a été délivrée au titre de la catégorie d’action suivante : ACTION DE FORMATION.
About CEHTRA
For 20 years we have specialised in assisting companies with the marketing of chemical substances and products in France, Europe and beyond.
Our toxicologists, ecotoxicologists and chemists provide you with their expertise to ensure the regulatory compliance of your products.
With a team of 70 people, we cover around ten sectors, including REACH, biocides, plant protection products, etc.