FDA 510(k) Regulatory Guidance

A trusted partner
for 510(k) support.

Dedicated regulatory team.

Croom Medical provides comprehensive 510(k) submission support services to assist our OEM customers in navigating the complex regulatory landscape of the medical device industry.

Our experienced regulatory team has a deep understanding of FDA regulations and requirements and can provide guidance throughout the entire submission process. We offer support for traditional, abbreviated, and special 510(k) submissions, as well as pre-submission meetings with the FDA. Our team also assists with post-approval compliance and ongoing regulatory support. A trusted partner for 510(k) submission support, ensuring that products meet the highest standards of safety and efficacy.


Joint Partnership

We help drive progress for our medical device customers by enhancing both their production capacity and their product and process innovation.

Manufacturing Capabilities

The facilities, technologies and processes to deliver end-to-end manufacturing.

Value-Add Capabilities

The team, expertise, and ingenuity to drive tangible added-value for our customers.

Get in touch

Find out how Croom Medical can help secure your supply chain and deliver world-class manufacturing solutions. Let’s discuss your project.


Email: [email protected]

Call: +353 61 397 744

"*" indicates required fields

This field is for validation purposes and should be left unchanged.
*Required Field.