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What You Need to Know About the EU MDR. Are You Ready?

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Schlafender Hase
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The EU MDR date of application is May 26, 2020, but are you ready for the changes? This user-centered legislation focuses on safety, quality and traceability, and has been a burning topic in the medical device industry since it greatly impacts the already complex labeling process for medical device manufacturers.

Watch this webinar to learn how the EU MDR will impact the medical device labeling process and how you can best prepare.

Play Video about Webinar: What You need to know about the EU MDR

Original Broadcast Date: November 19th, 2019
Length: 43 minutes

Do you need help with ensuring IFU correctness? To learn who TVT can help proofread your IFU updates prior to approval and eliminate multiple review cycles please contact us.

Presenters

Marketa Nabiany

About Markéta Nabiany

Markéta Nabiany is a consultant and project manager in the pharmaceutical and medical device industries in the area of product labelling and packaging. Markéta has spent the past 10 years managing a variety of global labelling projects within regulatory, quality, marketing, product development and supply chain. Markéta has supported organizations in creation and update of labelling-related processes on a global scale and contributed with her expertise to product usability during product development. Markéta’s special interests include instructions for use, patient and user documentation, as well as promotional labelling.

Schlafender Hase logo

About Schlafender Hase
Since Schlafender Hase® introduced its Text Verification Tool® (TVT), this software has taken the lead in providing intelligent, automated text and graphic proofreading solutions for the most regulated industries. Schlafender Hase’s client roster includes the world’s leading pharmaceutical and medical device companies. Schlafender Hase is proud to be known for product quality, service excellence and customer success. Founded in 2001, the company is headquartered in Frankfurt, Germany with a North American division in Cambridge, Massachusetts

Do you want to find out more about how your proofreading life can be easier? Get in touch and we’ll tell you all about it.

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The EU MDR date of application is May 26, 2020, but are you ready for the changes? This user-centered legislation focuses on safety, quality and traceability, and has been a burning topic in the medical device industry since it greatly impacts the already complex labeling process for medical device manufacturers.

Watch this webinar to learn how the EU MDR will impact the medical device labeling process and how you can best prepare.

Play Video about Webinar: What You need to know about the EU MDR

Original Broadcast Date: November 19th, 2019
Length: 43 minutes

Do you need help with ensuring IFU correctness? To learn who TVT can help proofread your IFU updates prior to approval and eliminate multiple review cycles please contact us.

Presenters

Marketa Nabiany

About Markéta Nabiany

Markéta Nabiany is a consultant and project manager in the pharmaceutical and medical device industries in the area of product labelling and packaging. Markéta has spent the past 10 years managing a variety of global labelling projects within regulatory, quality, marketing, product development and supply chain. Markéta has supported organizations in creation and update of labelling-related processes on a global scale and contributed with her expertise to product usability during product development. Markéta’s special interests include instructions for use, patient and user documentation, as well as promotional labelling.

Schlafender Hase logo

About Schlafender Hase
Since Schlafender Hase® introduced its Text Verification Tool® (TVT), this software has taken the lead in providing intelligent, automated text and graphic proofreading solutions for the most regulated industries. Schlafender Hase’s client roster includes the world’s leading pharmaceutical and medical device companies. Schlafender Hase is proud to be known for product quality, service excellence and customer success. Founded in 2001, the company is headquartered in Frankfurt, Germany with a North American division in Cambridge, Massachusetts

Do you want to find out more about how your proofreading life can be easier? Get in touch and we’ll tell you all about it.

Subscribe to our blog

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2 minutes read

TOPRA Sponsored Webcast: A Non-Technical AI Introduction for Regulatory Affairs Professionals

AI is already being used in many Life Science applications, meanwhile Health Authorities are looking to regulate the use of AI. As a regulatory affair professional, it is essential to have an understanding of this technology.    In this general introduction to the field of AI, different uses of the term "Artificial Intelligence" will be discussed, and which might be desirable in a given context.