Assent Risk Management is a progressive Risk and Resilience Consultancy built for the digital age. We pride ourselves on Championing International Standards and in this podcast we will be talking to experts from the consultancy industry, discussing standards, ISO’s, consulting and everything in between, to bring you industry knowledge and updates.
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Assent Risk Management is a progressive Risk and Resilience Consultancy built for the digital age. We pride ourselves on Championing International Standards and in this podcast we will be talking to experts from the consultancy industry, discussing standards, ISO’s, consulting and everything in between, to bring you industry knowledge and updates.
Understanding ISO 13485 for Medical Devices with Sarah Smith
Exploring Standards with Assent
9 minutes 2 seconds
6 months ago
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
Connect with Assent:
LinkedIn: https://www.linkedin.com/company/associate-enterprises-ltd-t-a-assent/
Facebook: https://www.facebook.com/assentuk
Youtube: https://www.youtube.com/channel/UCWw6ny-YyfkxdGm7ig4yFoQ
Instagram: @assentriskmanagement
Exploring Standards with Assent
Assent Risk Management is a progressive Risk and Resilience Consultancy built for the digital age. We pride ourselves on Championing International Standards and in this podcast we will be talking to experts from the consultancy industry, discussing standards, ISO’s, consulting and everything in between, to bring you industry knowledge and updates.
