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Medical Device Standards

If you are a medical device manufacturer, UserWorks can help you navigate the world of medical device regulations both in the United States and in the European Union.

Demystifying Device Requirements

Complying with medical device regulations isn't easy, but we know how important it is to get it right the first time. We'll help you to ensure not only that your device is usable, but also that it meets FDA and EU requirements so that you can confidently market your device in the U.S. and around the world.

UserWorks has partnered with The Johner Institute to provide medical device manufacturers a unique service for ensuring medical devices meet all relevant FDA and EU requirements, allowing you to bring your safe and effective device to market as quickly as possible.

Please check back soon to learn more about this exciting partnership, or contact us.