MORE EXPERTISE. SPECIALIZED KNOWLEDGE. BETTER RESULTS.

Boulder Regulatory Affairs and Quality Assurance provides full regulatory and quality support for medical devices and in-vitro diagnostic products.

Since 2009, our experts have helped companies navigate the process of getting medical device, in vitro diagnostic and digital health products to the market quickly.

SERVICE AND
RESPONSIVENESS

We offer comprehensive expertise and full capabilities under one roof.

SINGLE
SOURCE

We are laser-focused on identifying bottlenecks and solving problems with maximum detail and efficiency.

ENGINEERING
MINDSET

  • U.S. and international regulatory support
  • Extensive audit capabilities
  • Complete services with ISO 13485-compliant quality management systems
  • Clinical trial strategy and planning services
compliance rules and law regulation policy concept businessman working laptop computer on virtual screen, documents with checkbox lists

Boulder Regulatory Affairs and Quality Assurance partners with you through the entire process, offering customized services to ensure you get the results you need to bring your product to market – as quickly as possible.