Regulatory Affairs
Full domestic and international regulatory support for medical devices and IVDs — from classification and pathway strategy through FDA clearance and CE marking. We build the strategy first, run the testing inside our own family, and author submissions that are complete before they leave our hands.
FDA 510(k)
Predicate strategy, testing plans, and eSTAR-format 510(k) submissions that clear the first time.
De Novo
De Novo strategy and submission for novel Class I/II devices that have no valid predicate.
PMA
PMA strategy, module support, and clinical evidence coordination for Class III devices.
Pre-Sub / Q-Sub
Pre-Submission strategy and Q-Sub meeting support to de-risk your pathway with FDA early.
513(g)
When your classification or pathway is genuinely unclear, a 513(g) gets FDA’s formal read.
EU MDR / IVDR
Technical documentation, CER/PER, and Notified Body strategy for EU MDR and IVDR.
Not sure which pathway you need?
510(k), De Novo, or PMA? A 513(g) or a Pre-Submission resolves classification and pathway before you commit budget to testing. We help you make the call early.
Request a ConsultThe Boulder BioMed Family
One campus, one quality system. We manufacture, sterilize, and test medical devices in-house — so our regulatory and quality work is grounded in operations, not theory.