David Pudwill
David Pudwill
Medical Device Regulatory Expert & Former FDAer

Fostering Excellence & Collaboration in FDA Medical Device Regulation & Global Public Health

Expertise

Drawing upon our FDA experience, we provide regulatory and quality support to a variety of clients.

From large organizations to small startups and to those in regulatory and quality roles, we help bring safe, transformative medical devices to those who need them.

Community

Through videos, articles, and other tools, we empower the regulatory community to help build a healthier world.

Guidance

We're your guide to the FDA regulatory process and beyond with consulting, articles, video and support for all your needs.

FDA Guidance Review SeriesĀ 

Medical Device Review Series

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Regulatory Strategy

With a custom, realistic road map, we’ll help you through the entire regulatory process to get your product to market.

Q-Submission Support

We’ll help you prepare for interactions with FDA or develop a plan to address feedback you’ve received.

510(k), PMA, and More

Let’s get your pre-market submission cleared or approved, so you can sell your product in the US market.

Conscientious Innovation

The future is healthier and brighter with your medical device.

About Us

Explore the current issues in the regulatory space

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