JB & Associates

Specialties

JB & Associates provides FDA consulting services for the healthcare industry. Our team of experts includes regulatory affairs professionals, product design/​engineering firms and other regulatory professionals. We focus on medical product development and manufacturing, from concept through testing, clinical trials, FDA/​ISO regulatory compliance and ongoing manufacturing.

Contact JB & Associates Regulatory Consultants for…

IDE Submissions

Pre-​Market approval application assistance

Product Development — Design History Files

ISO and FDA regulatory affairs professionals

ISO 13 485 and ISO 9001 registration and certification consultants

Technical Files for CE Marking

Validations

Molding

Automated Assembly

Packaging

Product Software

Medical device development and manufacturing engineers

CE Mark/​Medical Device Directive (MDD) consultants

FDA QSR and product validation specialists

FDA and ISO audit advisors

Quality system consulting experts

FDA 510k notification/​submission specialists

History

Established in 2013.

In 2014, a group of Motorsports engineers joined together and began a journey into revolutionizing the components available to the aftermarket industry. The group of engineers comprised in Velox Motorsports have a wide range of previous and ongoing knowledge within the Motorsports world. We have worked within IndyCar teams and the sanctioning body, NASCAR teams, World Endurance Car (WEC) teams, as leading suppliers to the Motorsports industry, and in leading aftermarket companies as well. This vast experience allows us to cater to many needs within the automotive industry. With thoroughly engineered components including the use of Finite Element Analysis (FEA), thermodynamics, heat transfer, and Computational Fluid Dynamics (CFD), we strive to produce aftermarket parts that can outperform the factory components.