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Tips for a medical technology startup with a great idea

April 2, 2015 By Andrew Ahn Leave a Comment

Tips for a medical technology startup with a great idea

Pre-Validation

Filed Under: News Well, Regulatory/Compliance Tagged With: Regdy.com

10 advantages of getting your device approved by FDA

March 5, 2015 By Andrew Ahn Leave a Comment

10 advantages of getting your device approved by FDA

Playing within the lines of non-medical wellness toys is fun, but lets get serious. If you want your product to be seriously meaningful with direct impact to saving lives through diagnosis and treatment, you should expand your medical technology into the world of medical devices and undergo the submission process with FDA. Here’s why.

1. High Impact

Filed Under: News Well, Regulatory/Compliance Tagged With: Regdy.com

4 differences between how South Korea and USA view health tech

February 23, 2015 By Andrew Ahn Leave a Comment

4 differences between how South Korea and USA view health tech

Those who follow me know that I’m from San Francisco and now live in Korea. It’s been half a year and I’m going to share with my readers my experience on how Seoul views Health and Technology compared to San Francisco. Hopeful this will provide you with some market insight. Lets dive in.

Attitude Towards Tech Gadgets

Filed Under: News Well, Regulatory/Compliance Tagged With: Regdy.com

FDA warns Staar again over Calif. plant | Regulatory news for the week of February 16, 2015

February 17, 2015 By MassDevice Leave a Comment

FDA warns Staar Surgical again over California plant

February 11, 2015 by Brad Perriello

Filed Under: Food & Drug Administration (FDA), News Well, Regulatory/Compliance Tagged With: Pelvalon, Presbia, Regdy.com, STAAR Surgical Co

Regulatory affairs for medical device startups

February 13, 2015 By Andrew Ahn Leave a Comment

Regulatory affairs for medical device startups

Here’s a common short-sighted view that many medical device startups have:

The 510(k) submission is the End-All-Be-All

Filed Under: News Well, Regulatory/Compliance Tagged With: Regdy.com

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