When we talk about usability, I am sure you are unsure what should be done. Usually, we are also following a standard for that which is IEC 62366. In this episode, Amandine Broussier will specifically focus on one part of usability: the Summative Evaluation. She will explain what this is and when it should be done. So listen to this to be an expert in Usability.
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► Who is Amandine Broussier ?
Amandine Broussier is an independent medical devices usability specialist who supports medical device manufacturers in their usability engineering process (EN 62366-1:2015). She has 8 years of experience in usability engineering, working with around 30 manufacturers on different devices (hardware, software) (class II, class III, and IVD).
Amandine can help you through all stages of the usability engineering process including auditing your current usability documentation with recommendations for improvement, identifying of use-related risks, writing the different documents required by the EN 62366-1 standard, and carrying out your formative and summative evaluations for CE marking and FDA approval. She also provides introductions to usability engineering for companies to help them understand the expectations of notified bodies with regard to usability standards.
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► Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
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► Links from the Video
■ Amandine Broussier Linkedin Profile: /
■ IEC 62366-1 link: www.iso.org/fr...
■ IEC 62366-1/A1 link: www.iso.org/fr...
■ IEC 62366-2: www.iso.org/fr...
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► Social Media to follow
■ Monir El Azzouzi Linkedin: / melazzouzi
■ Twitter: / elazzouzim
■ Pinterest: / easymedicaldevice
■ Instagram: / easymedicaldevice
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#easymedicaldevice #medicaldevice #regulatorycompliance
9 сен 2024
