Sponsored Webinar: Ensuring Safety and Compliance

Sponsored Webinar: Ensuring Safety and Compliance
FREE SPONSORED WEBINAR - This engaging webinar is designed to guide participants through the preparation of technical documentation and clinical evaluation to meet regulatory standards in the medical device industry. Led by experts in MDR and ISO 13485 compliance, this session will offer practical insights and strategies for developing, structuring, and maintaining technical documentation in line with regulatory expectations.

2 December - 14:00 -15:00 GMT / 15:00 – 16:00 CET
Ensuring Safety and Compliance – From Technical Documentation to Clinical Evaluation

This engaging webinar is designed to guide participants through the preparation of technical documentation and clinical evaluation to meet regulatory standards in the medical device industry. Led by experts in MDR and ISO 13485 compliance, this session will offer practical insights and strategies for developing, structuring, and maintaining technical documentation in line with regulatory expectations.

Key Learning Objectives:

- Understanding Technical Documentation: Gain a comprehensive understanding of the essential components of technical documentation, including its role in ensuring device safety, performance, and compliance with regulatory standards.

- Best Practices in Compliance: Learn best practices for creating and maintaining technical files that are compliant with MDR/ISO 13485, covering everything from document structure to quality control and recordkeeping.

- Clinical Evaluation Report (CER) Essentials: Explore the core elements of the Clinical Evaluation Report (CER), which plays a critical role in supporting technical documentation by providing evidence of clinical safety and efficacy.

- Addressing Documentation Challenges: Discuss common challenges encountered in clinical evaluations, such as data interpretation and regulatory alignment, and explore practical solutions to overcome these hurdles.

- Integrating Clinical Evaluations: Discover how to effectively incorporate clinical evaluations as a vital component of technical documentation preparation, ensuring a holistic approach to safety and compliance.

Speaker: AJLA MUŠIC, M.Sc.Pharm, Pharmacovigilance Officer, Billev East
Ajla has experience in clinical research, pharmacovigilance, regulatory affairs and of human medicines and medical devices. Passionate about advancing healthcare and pharmaceutical innovation. 

This webinar is sponsored by Billev East.



Disclaimer: Whilst TOPRA is running this webinar for Billev East, this is not an endorsement of Billev East, Billev East's affiliates, employees or its products and services. TOPRA is also not responsible for the content or views expressed during the webinar.

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Pricing

  • Members: free
  • Non-members: free

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When
02/12/2024 14:00 - 15:00
Where
ONLINE
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