About me
Expertise fields
Languages
Français
프랑스어 – French
English
Anglais – 영어
한국어
Coréen – Korean
Main skills
A little insight into what I can do... set apart medical device evaluation
Project Management
Data Analysis
Process Improvement
LATEST ARTICLES
Last MDRD – Date of Application
Welcome to my last MD Regulatory Digest! As you probably noticed, there is only 1 year left until the Date of Application of the MDR. With this anniversary, my series[…]
MDRD 8 – PMS
Welcome back to my 8th MD Regulatory Digest! This week I decided to focus on the PMS & Vigilance. This topic is part of the early obligations that any manufacturer[…]
MDRD 7 – ‘Making available‘
Welcome back to my 7th MD Regulatory Digest! This week I made a focus on 3 terms defined in the Article 2 of the MDR: ‘making available on the market’,[…]
MDRD 6 – UDI
Welcome back to my 6th MD Regulatory Digest! This week I decided to focus on the UDI System, and more specifically on the difference between UDI and Basic UDI-DI. This[…]
MDRD 5 – New Economic operators
Welcome back to my 5th MD Regulatory Digest! This week my Digest is about new economic operators, focused on importer, distributor and authorized representative. I hope you enjoy it! Download[…]
MDRD 4 – Scope
Welcome back to my 4th MD Regulatory Digest! One of the 1st points to consider for any MD manufacturer or distributor is the scope of the MDR, which is wider[…]
MDRD 3 – Manufacturer
Welcome back to my MD Regulatory Digest! As I mentioned in my 1st digest, the Regulation (EU) 2017/745 brings a lot of changes. Naturally, the manufacturer is an economic operator that[…]
MDRD 2 – Timeline
Welcome back to my MD Regulatory Digest! This week, I made a focus on the transition timeline of the Regulation (UE) 2017/745. Of course, I only selected most important dates[…]
Welcome to the MD Regulatory Digest!
Welcome to the MD Regulatory Digest! Every 2 weeks, I will share with you an overview of the latest news in the Medical Device Industry as well as a focus[…]