Navigate regulatory nuances for your SaMD by following a structured approach to maintain compliance post-release.
Follow this framework to ensure your SaMD conforms to HF standards post-release
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Anke Adenwala
Partner
Anke has spent more than 7 years in the UX field. Much of her recent work has been in the healthcare space, specifically with medical device manufacturers to coordinate and execute human factors research programs. Her experience ranges from exploratory work, through small- and large-scale formative studies, to 510k validation studies, having supported successful submissions and several publications. With a background in social science, Anke enjoys interacting with people to better understand how the devices they interact with impact their lives, and how to optimize these tools to create better experiences. Anke has lived and studied in three countries and speaks German and French. Anke holds an MA in Social Science from the University of Chicago.
Bold facts
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Anke
Something unique about you summed up in one sentence
I love to travel (off the beaten path if I have to, but I do enjoy running water where I can get it)–I’d choose mountains over beaches any day.
Your favorite part of working at Bold Insight
The people. The work. I know that’s all of it, but I love it all.
In your spare time (or if you had spare time), you would absolutely do this:
Turn on a good BBC murder mystery (the great British Bake Show would work too), lounge on the couch or bake something.
How long have you been in the UX field?
10+ years
Your favorite city in the world is...and why?
Chicago…it’s home. Hard to pick a favorite to visit. Paris, Istanbul, Auckland, Queenstown all come to mind.
You cannot start the day without doing this:
Having breakfast and a hot cup of chai
Your ultimate celebrity dinner party guest list would include:
Agatha Christie (have to thank her in some way for giving me years of reading entertainment) and Anne Boleyn (would probably regret this, but I have to know–was she scheming and power-hungry or just an innocent pawn?)
Long-term personal or professional goal?
Not really
Read Anke's bold insights
- Bold Insight to launch AI research project at the 2024 HFES Health Care Symposium
- Bold Insight to showcase digital IFU design, remote testing, global research expertise at virtual human factors health care conference
- Bold Insight to showcase digital IFU design, global research expertise at human factors health care conference
- When designing an experience, are you really thinking about the customer first?
- Reclassifying diabetes: 3 implications for product design
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