E-tečaj za interne revizore sustava upravljanja kvalitetom ISO 9001: 2015

Biocompatibility of medical devices

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 exchange of experiences.

Attendees may send their questions at registration prior to the workshop.

The online training will take place in a live online e-classroom. Each day 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.