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:
Popular Podcasts
24/7 News: The Latest
The latest news in 4 minutes updated every hour, every day.
Stuff You Should Know
If you've ever wanted to know about champagne, satanism, the Stonewall Uprising, chaos theory, LSD, El Nino, true crime and Rosa Parks, then look no further. Josh and Chuck have you covered.
Crime Junkie
Does hearing about a true crime case always leave you scouring the internet for the truth behind the story? Dive into your next mystery with Crime Junkie. Every Monday, join your host Ashley Flowers as she unravels all the details of infamous and underreported true crime cases with her best friend Brit Prawat. From cold cases to missing persons and heroes in our community who seek justice, Crime Junkie is your destination for theories and stories you won’t hear anywhere else. Whether you're a seasoned true crime enthusiast or new to the genre, you'll find yourself on the edge of your seat awaiting a new episode every Monday. If you can never get enough true crime... Congratulations, you’ve found your people. Follow to join a community of Crime Junkies! Crime Junkie is presented by audiochuck Media Company.