What is the formative study

>> YOUR LINK HERE: ___ http://youtube.com/watch?v=5k3fIzmXia4

The Medical Device field is so big that we have a specialist for each type of area. This is like a Surgeon who is a specialist in the heart, the orthopedic… Here we have with us a specialist for Usability, and this is really a big field that you need to understand. IEC 62366 is a standard that is important to know as all devices that have a user interface should show they can be safe, and that the user understands it. So, don’t miss this episode. • ------------------------------------------------------------------------------------------------------------------------ • ► Who is Michael Engler? • Senior Consultant, Managing Partner at Benkana Interfaces GmbH Co. K • I am working as an expert in Usability Engineering and Requirements Management as a Trainer, Consultant, and Coach. I am also consulting on software process improvement, helping my clients to deliver their software products on time, within budget, and quality, especially in medical device software and other industries. • Specialties: Usability Engineering, Requirements Engineering, knowledge in medical device software development (EN 62304, EN 62366, EN 14971, EN 13485; FDA: Chapter 21 Part 820, Chapter 21 Part 11, and relevant guidance documents), excellent Project Management skills, ability to see the big picture, connecting well with people, SPICE Assessor, Trainer for IREB Certified Professional in Requirements Engineering. • ------------------------------------------------------------------------------------------------------------------------ • ► 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 an Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device has become a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. • -------------------------------------------------------------------------------------------- • ► Links from the Video • ■ Michael Engler LinkedIn Page: / michael-engler-benkana • ■ Benkana Interface website: https://www.benkana-interfaces.com/ • ------------------------------------------------------------------------------------------- • ► Social Media to follow • ■ Monir El Azzouzi Linkedin: / melazzouzi • ■ Twitter: / elazzouzim • ■ Pinterest: / easymedicaldevice • ■ Instagram: / easymedicaldevice • ------------------------------------------------------------------------------------------ • #easymedicaldevice #medicaldevice #regulatorycompliance

#############################

New on site