Why Design History File (DHF) is so important? [Alexandros Savvidis]
DHF or Design History File or DMR or DHR or … What does all this mean? We will focus on DHF but we’ll also provide an explanation of the other acronyms.
In this episode of the Podcast, Alexandros Savvidis will share with us his experience. He’ll provide some examples. So don’t hesitate to check this episode if you are willing to get more understanding and ask your questions in the comments.
Who is Alexandros Savvidis?
Alexandros Savvidis is a Senior Medical Device Specialist active more than 17 years in multiple areas including Regulatory Affairs, Quality Management, R&D, Sales, Technical Support & Analysis.
After his studies in Biomedical Engineering, he has worked in the medical devices as also the pharma packaging industry across Europe in Germany, Switzerland, Netherlands, UK, and Greece. He has organized and contributed as an RA Specialist to various successful international certifications of medical devices of all classes.
Alexandros has gained one overall experience and deep understanding through his various roles on the full norm compliant development and certification process, like many other aspects like GMP, quality, risk management, vigilance, or clinical evaluations.
He has worked on small, middle-size companies alone or a team member, or even on cross-functional teams of Life Science Giants. In the last years is his main focus is the implementation of MDR requirements and updates
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…
Links from the Video
- Alexandros Linkedin Profile: https://www.linkedin.com/in/alexandrossavvidis/
- What is a DHF?: https://www.greenlight.guru/glossary/design-history-file