Services to Ease FDA Regulatory Compliance

FAQ: Medical device

What are the requirements for marketing medical devices in the United States?

This depends on the type of medical device you are intending to market. The FDA has established both general requirements and special requirements. General requirements include establishment registration, device listing, proper labeling and GMP, which are applicable to most devices. Special requirements – such as Pre market notification and Pre market approval – are applicable to … Continue reading What are the requirements for marketing medical devices in the United States?

How we can help to market your medical device?

Pragmatic supports companies to classify their medical devices and identify the applicable regulatory requirements. Our complete solution takes through each stage of the requirements.

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