🇨🇿 New strategy for assessing biocompatibility: What ISO 10993-1:2025 brings

The event is held in Czech language only!

The revision of ISO 10993-1:2025 introduces new requirements, but also a new way of thinking about biocompatibility. The standard has been completely reorganized to reflect the decision-making logic of risk management, while emphasizing that biological evaluation is not an isolated process. It is part of an overall risk assessment that evolves with the device – from material selection to changes in manufacturing. Join our online seminar to gain valuable advice and insight into the new revision of ISO 10993-1:2025.

The webinar will explain what has changed from the previous version of the standard, what new requirements manufacturers must meet, and how to properly incorporate biocompatibility assessment into the overall technical documentation. It will also focus on the general principles and procedures of biological evaluation: correct determination of exposure, categorization of contact, identification of biological hazards, and selection of appropriate procedures for testing and when it is more appropriate to use scientific reasoning and existing data.

Who the webinar is for:

• Manufacturers' regulatory specialists

• Employees responsible for biocompatibility assessment and risk management of medical devices

• Those interested in expanding their knowledge of biological safety requirements and the new ISO 10993-1:2025 standard

• Anyone working in the medical device industry who wants to broaden their horizons on this issue

Lecturers:

• Sidónia Molitorisová

• Magdalena Folkmanová

Content:

• Basic principles of biological evaluation of medical devices (within the risk management process)

• Key changes in ISO 10993-1:2025 and their impact on biological evaluation strategy

• Biocompatibility evaluation within risk management

• Correct categorization of contact and determination of exposure, the role of material and chemical characterization

• New requirements for the qualification of the lead author of the biocompatibility assessment and increased emphasis on ethical testing practices (3R principles)

• The most common shortcomings and how to prevent them in technical documentation

• Prerequisites for biological evaluation

  
  

Additional information:

• During the webinar, participants will have the opportunity to ask questions

• Each participant will receive a certificate of participation

• A PDF presentation will be sent to all participants

Participation fee:

• 3.900 CZK excluding VAT

• 100% cancellation fee applies after bindingly confirmed registration, but with the possibility of sending a replacement participant

Webinar hosted by:

• Porta Medica s.r.o.

• ID: 03301931, VAT: CZ03301931

• Registered office: Opletalova 1525/39, 110 00, Prague 1 - Nové Město