EUDAMED is delayed, so What? with Richard Houlihan
EUDAMED is delayed but what should do Medical Device manufacturers to continue be compliant. Richard Houlihan is a EUDAMED expert and will help us understand. The post EUDAMED is delayed, so What? wit...
18 Nov 20190s
Literature Search for your CER with Ed Drower
When creating your Clinical Evaluation Report or CER, you maybe need to perform a literature search. There is a certain method for that and we wanted to help you to understand it with Ed Drower from C...
11 Nov 20190s
Medical Device School: How to build a Gap Assessment Tool?
In this Bonus episode of Medical Device School we will talk about Gap Assessment tools. You know that when there is a regulation or something that you should put in place, you need to perform a gap as...
7 Nov 20190s
How to validate an eQMS with Jacob Sjorslev
After episode 47 on how to implement an eQMS, Jacob Sjorslev is now telling us how to validate an eQMS. This is something mandatory now since ISO 13485:2016. So listen carefully and download the givea...
4 Nov 20190s
How to implement an eQMS with Jacob Sjorslev
An eQMS can be a necessary tool for your Quality Management System. This is why it's implementation should be executed as a project. Jacob Sjorslev will be your instructor and tell what to do and what...
28 Okt 20190s
Medical Device School – Most important issues on your CAPA (ISO 13485)
On the Medical Device School segment, we will help you understand how to be better with your CAPA system. Stefan Bolleininger and Monir El Azzouzi are sharing with you their experience. The post Medic...
24 Okt 20190s
Medical Device Disruptions at Hospitals with Stefan Krojer
Some signs are raising from Hospitals regarding disruptions on Medical Devices. What is exactly the reason. Stefan Krojer will share with us his experience and a solution he is developing. The post Me...
20 Okt 20190s
5 FDA Myths for Start-Ups with Justin Bushko
Justin Bushko from Concise Engineering will share with us 5 FDA Myths that exist on the Start-up world. Medical Devices Start-Ups should satisfy Investors and Regulatory, and this can create some stra...
14 Okt 20190s
