Medical Devices → United States

Expert Regulatory Support for Entering the U.S. Medical Device Market

The U.S. is the largest and one of the most strictly regulated medical device markets, overseen by the FDA. Manufacturers must register their establishments, list their devices, obtain FDA clearance or approval (510(k), PMA, or De Novo), follow Quality System Regulations, and use UDI labels with data submitted to the GUDID. Obelis supports manufacturers with strategy and regulatory guidance to achieve FDA approval, maintain compliance, and successfully launch devices in the U.S. market.

Get in touch

Discover our Services

Get in touch

US Agent & Official Correspondent

US Establishment Registration

FDA Device Listing

Label Review & UDI Support

Medical Device Reporting

Regulatory Consultancy

MDlaw.eu is the internet's most extensive information platform on medical device law.

Explore

Other Regions

Our international standing means we offer compliance services around the globe. This makes us an ideal choice for manufacturers who market their products in several global markets.

United Kingdom

The United Kingdom’s medical device market remains a key opportunity post-Brexit, but requires navigating its own regulatory framework, including UK-specific compliance for market access.

European Union

The European Union medical device market, serving over 500 million patients, offers vast opportunities but requires strict compliance with Regulation (EU) 2017/745 (MDR).

Switzerland

Switzerland’s medical device market is innovation-driven and closely aligned with EU standards, but requires non-Swiss manufacturers to meet national obligations.

Industry News

View all

Start your compliance journey with Obelis.

Get in touch