Lilla StrobelTech Regulatory | Quality ConsultantSome time ago
Do you have a revolutionary medical product idea? Now what? You better start with MDR, to decide if it is a medical device! You will thank later! # medicalproduct #medicaldevice
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Lilla Strobel on FDA - medical devicesTech Regulatory | Quality ConsultantSome time ago
The ballad of Elizabeth Holmes We all heard the story about the infamous company Theranos. The former CEO, the ambitious Princeton dropout has announced her pregnancy. Ok, it was predictable, who on earth could be mad at a pregnant woman with angelic blond hair and piercing blue eyes. Smart. Hopefully his ex-partner won't do the same ๐Ÿ˜… On the other hand, as a regulatory manager I always wondered how she could do this alone? My answer is: she couldn't, everyone around her was in this fraud, but it was worth for everyone. She made a lot of things wrong, but she couldn't do it without a ton of help. For me, the former colleagues who are now saying she was pure evil, sound hypocrite. They say, that healthcare is not like other tech, you can't say fake it until you make it. Honestly, medtech companies must say it like every other companies, and they do. Regulatories also made mistakes, they didn't even try to apologize. They let this device start a clinical trial without making sure it is working, which is not unusual. The stores bought the Edison made a mistake, because they check the documentation before purchasing. Fun fact: if you buy a medical device it is your responsibility to check if it is certified. I think she did so many things wrong but she didn't do it alone, and now she has to bear the consequences almost alone.
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Aurelija Lapฤ—naitฤ—-Sytฤ— on Have baby, will travel!Corporate warrior, Marketing expert, Loving mother, People managerSome time ago
An excersice / works both solo & in family: Write down things, that you want to achieve. Write down things, that you actually do everyday. Make a list if things, that makes you happy today. Compare.

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Aurelija Lapฤ—naitฤ—-Sytฤ—Corporate warrior, Marketing expert, Loving mother, People manager
Contemplate & adjust if needed. In my โ€œbubbleโ€, we tend to do things that needs to be done, and undermine things that makes one happy.
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If you still believe your words are unworthy to share, you are ๐•‹๐”ผโ„โ„๐•€๐”น๐•ƒ๐• wrong... One little phrase can change someone else's mind and here are the books with stories that will encourage you: โ—‡ ๐“๐“ท๐“ญ ๐“ฃ๐“ฑ๐“ฎ๐“ท ๐“˜ ๐“œ๐“ฎ๐“ฝ ๐“œ๐“ช๐“ป๐“ฐ๐“ช๐“ป๐“ฎ๐“ฝ: ๐“ข๐“ฝ๐“ธ๐“ป๐“ฒ๐“ฎ๐“ผ ๐“ธ๐“ฏ ๐“Ÿ๐“ฎ๐“ป๐“ผ๐“ธ๐“ท๐“ช๐“ต ๐“ฃ๐“ป๐“ช๐“ท๐“ผ๐“ฏ๐“ธ๐“ป๐“ถ๐“ช๐“ฝ๐“ฒ๐“ธ๐“ท Book by Rob White will teach you how to learn from other's around, and the simple truth, - that being yourself is more than enough. My honest review of the book: https://forums.onlinebookclub.org/viewtopic.php?f=24&t=71537 โ—‡๐“ฃ๐“ฑ๐“ฎ ๐“ฆ๐“ฒ๐“ฝ๐“ฌ๐“ฑ ๐“ธ๐“ฏ ๐“Ÿ๐“ธ๐“ป๐“ฝ๐“ธ๐“ซ๐“ฎ๐“ต๐“ต๐“ธ By Paolo Coelho will empower you to spread the little knowledge you got And โ—‡ ๐“ฃ๐“ฑ๐“ฎ ๐“ข๐“ฎ๐“ฌ๐“ป๐“ฎ๐“ฝ ๐“›๐“ฒ๐“ฏ๐“ฎ ๐“ธ๐“ฏ ๐“œ๐“ช๐“ป๐“ฒ๐“ต๐”‚๐“ท ๐“œ๐“ธ๐“ท๐“ป๐“ธ๐“ฎ Book by J. Randy Taraborrelli, will open your eyes to how a person with bipolar disorder managed to make the whole world fall in love with her. If she did it, you can do it too!
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