Online Workshop

The workshop and materials will be in the English language.

Biocompatibility of medical devices is an important characteristic of safe and compliant medical devices. The main steps for ensuring biocompatibility are specified in ISO 10993-1 standard.

Intention

Attendees will participate in a workshop on the preparation of medical device biological evaluation reports covering chemical characterization of materials, documentation preparation, and justification of testing performance or its omission (cytotoxicity, irritation, sensitization, systemic toxicity, genotoxicity, carcinogenicity). All these issues will be discussed through practical examples.

Content

• Presentation of requirements for biological safety evaluations of medical devices in medical device directives and regulations, as well as ISO 10993-1 and other relevant standards
• Review of the ISO 14971 standard in relation to biological safety – preparation of a biological evaluation report concerning biological risks
• Methodology and biological evaluation report preparation
• Summary of ISO 10993-1 with practical discussions

Methodology

The workshop is will cover the theoretical basics and requirements through practical examples and an exchange of experiences.
Attendees may send their questions at registration prior to the workshop.

Lecturer Marjetka Kralj Kunčič PhD is a doctor of science in the field of microbiology with more than 12 years of experience in the manufacturer of medical devices. Her work was extensive, as in addition to managing laboratories, as the head of quality control, she also actively participated in the field of development, production, and ensuring legislative compliance, as well as the compliance of the quality system of medical devices. She currently works as an auditor at SIQ and a consultant in the field of medical devices and is a member of the technical group for the preparation of the standard.

The online workshop will take place in a live online e-classroom and will be divided into three parts with breaks in between.
Up to two days before the implementation, registered participants will receive a link to the online training. Participants need a computer with a microphone and a camera, as well as access to a reliably functioning internet connection to participate in online training without interruption.

Certification procedure

Main steps in the process of obtaining the CE mark and more about the certification procedure according to Regulation (EU) 2017/745 and ISO 13485 you can find HERE.