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| 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. |
IntentionAttendees 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.
Course and materials will be in English language.
| | Lecturer Marjetka Kralj Kunčič PhD is a Doctor of Science in microbiology with more than 17 years of experience in quality management systems. Her previous wor with a medical device manufacturer included not only laboratory management and quality control, but also active involvement in the development, production and regulatory compliance of medical devices, as well as quality management system compliance. Currently, she works as an SIQ auditor and a consultant in the field of medical devices and a member of the technical group for the preparation of health protection standards. |
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 certification procedure according to Regulation (EU) 2017/745 and ISO 13485 you can find HERE.
Additional information: Bojan Varga, phone: +386 1 477 81 08, e-mail: bojan.varga@siq.si
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