Tuesday, 02 January 2024 12:17 GMT

2 Day Virtual Biological Evaluation Of Medical Devices Training Course: Ensure Compliance With The ISO 10993 Series Of Standards For The Biological Evaluation Of Medical Devices (Jan 21St-22Nd, 2026)


(MENAFN- GlobeNewsWire - Nasdaq) Opportunities include mastering ISO 10993 standards for medical device compliance, crucial for EU MDR adherence. Leverage insights on biological risk management, FDA approaches, and global safety standards to enhance device safety and market access.

Dublin, Nov. 03, 2025 (GLOBE NEWSWIRE) -- The "Biological Evaluation of Medical Devices Training Course (Jan 21st - Jan 22nd, 2026)" training has been added to ResearchAndMarkets's offering.

Ensure compliance with the ISO 10993 series of standards for the biological evaluation of medical devices, as it is well-established and expected by regulatory authorities worldwide.

In the European Union, compliance with these standards is crucial for meeting the essential safety requirements outlined in the Medical Device Regulation (MDR). Understanding and implementing a comprehensive risk management strategy for biological safety is therefore paramount.

This seminar offers essential guidance on effectively utilising the ISO 10993 standards and integrating a robust risk management approach into the biological evaluation process of medical devices. Participants will have ample opportunity to engage in interactive discussions with industry experts, gaining practical insights and best practices.

Attendees will emerge equipped with the knowledge and tools necessary to navigate regulatory requirements, mitigate risks, and ensure the safety and efficacy of medical devices in compliance with global standards.

Benefits of attending

  • Understand biological risk management
  • Clarify the requirements of ISO 10993-1
  • Learn what endpoints need to be addressed in a biological risk assessment
  • Establish how much chemical characterisation is necessary
  • Explore the FDA's approach to ISO 10993
  • Comprehend the Medical Device Directive (MDD) safety requirements vs the Medical Device Regulation (MDR) safety requirements
  • Recognise how extractables and leachables impact medical device safety
  • Discuss the Japanese and Chinese requirements

Certifications:

  • CPD: 12 hours for your records
  • Certificate of completion

Who Should Attend:

  • Regulatory affairs
  • R&D
  • Product safety/toxicology
  • Analytical chemistry
  • Risk assessment and risk management
  • Materials research and evaluation

It will also be of interest to regulatory authorities, Notified Bodies and CROs supporting the medical device industry.

For more information about this training visit

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