The EU MDR is just around the corner. Let us reflect.
We take fasting as a principle and prepare for the upcoming events: There is still a lot for you to do before the Medical Device Regulation MDR 2017/745 comes into force for the EU in May 2021. Fast for lean quality management systems, focus on the key issues when it comes to risk management and usabiliy, shed unnecessary requirements ballast and establish clarity in obtaining clinical data for manufacturers.
Fast for 40 days for MDR so that you are equipped for Easter and ready for Pentecost for the end of the transition period in the EU.
And how do we want to fast with you?
Of course, the preparation and responsibility lies with each individual producer, and you yourself will know best whether you have really achieved your goal. But to make sure you take the right path, we are happy to offer you assistance.
From 15 February 2021 to1 April 2021, we will guide youthrough varioustopics and answerquestionsthey arise inahalf-hour web session:
Friday, 19.02.2021 11:00-11:30
Crossover training for your international technical documentation
Friday, 26.02.2021 11:00-11:30
Legs, Bums and Tums for the TechDok - fit for the MDR
Friday, 05.03.2021 11:00-11:30
Conquer Mount “GRUSULA” (GSPR)
Friday, 12.03.2021 11:00-11:30
Risk analysis - let the games begin!
Friday, 19.03.2021 11:00-11:30
Fitness trackers in use - UDI & Vigilance
Friday, 26.03.2021 11:00-11:30
Clinical evaluation - the stable backbone of your compliance
Thursday, 01.04.21 11:00-11:30
Medical devices without yo-yo effect - Post Market Surveillance
You would like to join the fasting and prepare yourself?
Then register during the respective fasting week between Monday and Thursday by 12 noon (for the session on 1 April, Wednesday is the registration deadline). Use our contact form or our regulatoryaffairs(at)seleon.de email for this purpose.
Please provide your contact and company details as well as any specific questions you may already have on the topic so that we can invite you to the web session on time.
Please note that all details and listings do not claim to be complete, are without guarantee and are for information purposes only.