Wednesday Apr 16, 2025
Understanding ISO 13485 for Medical Devices with Sarah Smith
In this episode of Exploring Standards, host Jess is joined by Sarah Smith, a highly experienced consultant specialising in ISO 13485 Medical Devices and ISO 9001 Quality Management. With over ten years of experience in the medical device industry and expertise as a certified data protection officer, Sarah provides invaluable insights into the world of ISO 13485 and its importance for medical device manufacturers.
In this episode Sarah explains why this standard is essential for ensuring quality and compliance in the medical device industry, breaking down the key components of an ISO 13485 Quality Management System (QMS).
The episode also explores the role of risk management in ISO 13485 and how it helps organisations address potential challenges. Sarah clarifies the differences between ISO 13485 and Good Manufacturing Practice (GMP) and highlights how ISO 13485 supports compliance with key regulations in the UK and Europe.
Whether you're in the medical device industry or simply curious about how international standards impact healthcare, this episode is packed with practical insights and expert advice. Tune in to learn how ISO 13485 can help organisations ensure safety, quality, and regulatory compliance.
Contact Sarah:
https://www.linkedin.com/in/sarah-s-09928b105/
Contact Assent:
- Website: www.assent1.com
- Email: desk@assent1.com
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