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SaMD or SiMD - How to create a Design Dossier?

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Episode 195
33 min / Published

If you have developed a Software and you discover that it is considered a Medical Device, then what to do? Or your Software is inside a Medical Device so is this different than normal Medical Devices? In this episode with Anindya Mookerjea from Scube-technologies, we will explain to you the step that you need to follow to create a Design Dossier for your product. This is an important step as this is required for certification by the authorities. So let’s dig into it.

Who is Anindya Mookerjea?

Anindya is the founder and CEO of S-Cube Technologies. He has over 20 years of experience in the medical device & Software industry. Experienced in taking medical device concepts through design & development, regulatory submission, and to market. Expert in the design, development, and implementation of FDA/ISO compliant quality management systems for Medical devices & Software medical devices. Industry expert in Agile methodology implementation for Software medical devices. Strong background in testing Software medical devices. The brainchild of SmartEye product.

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 and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. 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 is also acting 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.

Links

Medical Device made Easy Podcast
A podcast by easymedicaldevice
Helping you placing compliant medical device on the market.
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