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<!DOCTYPE html>
<html lang="en" data-theme="light">
<head>
<meta charset="UTF-8" />
<meta name="viewport" content="width=device-width, initial-scale=1.0" />
<title>PatwardhanMed Consulting</title>
<link
rel="icon"
type="image/x-icon"
href="./resources/assets/icon/favicon.ico"
/>
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<a class="navbar-item is-tab" href="./index.html"> About </a>
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People
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<div class="content">
<div class="pc-user-name">
<h1>Yashaswini Patwardhan</h1>
<a href="https://www.linkedin.com/in/patwardhanmed/">
<img
style="
height: 1.5rem;
padding: 0 4px;
box-sizing: content-box;
"
src="./resources/assets/icon/linkedin.png"
alt=""
/>
</a>
</div>
<span class="tag is-primary is-medium">Founder</span>
<span class="tag is-info is-medium">Consultant</span>
<span class="tag is-info is-medium">US & EU</span>
<hr />
<p>
Yashaswini Patwardhan started her journey in the medical device
industry 17 years ago as an intern in Los Angeles and graduated
with an MS in Biomedical Engineering from the University of
Southern California shortly after. The intern position led to a
job opportunity in Buffalo, New York in 2006, where she worked
with both small and large medical device manufacturers within
Western New York. During these 8 years, she gained a solid footing
in 21 CFR Part 820 quality management systems (QMS) requirements
and 510 (k) market authorization pathway.
</p>
<p>
When an opportunity arose to join a consulting project in 2014,
she engaged fully. This decision was truly life changing, since it
meant working on a project in Germany alongside other consultants.
The 3.5 years there grew her professional network internationally
and further enhanced her knowledge and experience in FDA QMS
remediation and eventually led to her first project tackling CE
marking. With the introduction of MDR around that time and its
coming into force in May 2021, it has been a whirlwind of activity
assisting clients with MDD-MDR transition both in Europe and the
USA, while also being engaged in FDA enforcement action related
QMS remediation. Amid all this, in August 2021 Yasha acquired an
Executive MBA from the Quantic School of Business and Technology.
</p>
</div>
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</div>
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<!-- Slide 1 -->
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<div class="testimonial-text">
Your exceptional support during the MDR project is
invaluable. Your commitment to understanding our product
families and processes ensures that our needs are met. Your
proactive approach in addressing LoQs and identifying areas
for improvement is commendable. The RA EMEA Team deeply
appreciates your dedication.
<br />
<div style="text-align: end">Johnson and Johnson Vision team</div>
</div>
</div>
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Your expertise shines through in every interaction. Your
willingness to collaborate and share insights elevates our
team. Your attention to detail and commitment to excellence
make the MDR transition smoother. We’re grateful for your
contributions.
<br />
<div style="text-align: end">Johnson and Johnson Vision team</div>
</div>
</div>
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Your technical acumen is a game-changer. Your adaptability
to our context and your thoughtful proposals for addressing
LoQs demonstrate your brilliance. Your cultural insights
enrich our team. Thank you for being an asset.
<br />
<div style="text-align: end">Johnson and Johnson Vision team</div>
</div>
</div>
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Your impact extends beyond projects. Your dedication fosters
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value your professionalism and kindness.
<br />
<div style="text-align: end">Johnson and Johnson Vision team</div>
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Your multifaceted contributions resonate deeply. Your
unwavering support during the MDR transition sets a high
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fortunate to have you—a true team player.
<br />
<div style="text-align: end">Johnson and Johnson Vision team</div>
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<div>Eggenstein-Leopoldshafen, DE <br /></div>
<div>
<a class="subtitle pc-subtitle" href="tel:+491608137497"
>+49 160 813-7497</a
>
</div>
<div>
<a
class="subtitle pc-subtitle"
href="mailto:[email protected]"
>info @ patwardhanmed.consulting</a
>
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>People</a
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© 2024 PatwardhanMed Consulting. All rights reserved.
</p>
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