YOUR SELEON SPECIALIST

Anne Matousek
Senior Consultant QM & RA, Regulatory Affairs Expert

Tel.: 07131 2774-40
regulatoryaffairs(at)seleon.de

Questions on this topic?

Send us a message!

 

08.02.2021

FASTING – WITH A FOCUS ON THE MDR

With a focus on the essentials, the one or other extra pound (not only on the scales, but also in the company process) becomes clear. Put your risk management in order, get an overview of clinical data and more.

fasten-fuer-die-mdr-mit-seleon
fasten-fuer-die-mdr-mit-seleon
fasten-fuer-die-mdr-mit-seleon
fasten-fuer-die-mdr-mit-seleon

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.

By registering you agree that your data will be used in accordance with our privacy policy.

 

Please note that all details and listings do not claim to be complete, are without guarantee and are for information purposes only.

Every product is unique – the mandatory tasks and measures for entering the market need to be specified individually. seleon advises you on your individual questions without any obligation.

CONTACT YOUR SELEON SPECIALIST

Further entries from the "Regulatory Affairs" category

Regulatory Affairs
10.02.2021

Trade with the United Kingdom will become more complicated after Brexit, also with regard to the medical devices sector. Among other things, every company must mandate a UK responsible person in order to achieve the UKCA.

Regulatory Affairs
08.02.2021

With a focus on the essentials, the one or other extra pound (not only on the scales, but also in the company process) becomes clear. Put your risk management in order, get an overview of clinical data and more.

Regulatory Affairs
14.01.2021

About a year ago we reported for the first time on the changeover from MEDDEV to MDCG. Time to take a look at what has happened so far.

In 2020, the MDCG published a total 28 documents. The topics are varied.

Clinical Affairs

Clinical affairs of medical devices requires numerous evidences and evaluations. What we know about it …

 

> Clinical Affairs

Quality Management

Medical devices are governed by stringent requirements on quality assurance. We know the details …

 

> Quality Management

Development Excellence

Product development of medical devices is subject to its own rules. We bring light into the darkness …

 

> Development Excellence