Michaela Hajek
Managing Director at 3r Lifescience Gmbh
Based in Berlin, Germany
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Seniority
C-Team
Department
General Business & Management
Location
Berlin
Industry
Medical Equipment Manufacturing
Company size
7
Contact information
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m•••••••@3r-lifescience.com
Phone
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Background
About Michaela Hajek
Medical devices must be safe and efficient. To prove this, regulatory requirements must be met. And this is where the difficulties begin. Because: Medical devices have to be tracked throughout their entire life cycle. New standards and requirements are constantly being added. A company's quality management must be adapted to the changing conditions for the development and approval of medical devices I have been in the medical technology industry for over 20 years and know the challenges, especially in the areas of regulatory and quality management. As Managing Director of 3R LifeScience, I try to show my clients that regulations and the management of medical device quality go hand in hand and, properly applied, enable efficient market approval. The result is: Standards and requirements do not complicate development, but make it more target-oriented Structured specifications make development fun again for employees A QMS works well when it takes into account the competencies and goals of an organisation and its employees. Interested? Please get in touch with me!
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