Who We Are
With strong and solid industry expertise, A Wright Path® navigates and executes the FDA and global regulatory requirements and submissions so our clients can achieve the launch of their products with confidence into the marketplace. We interface with regulatory agencies on your behalf while acting as your strategic partner. We offer strategy and quality solutions in the following industries:
How We Help
We see your product through its entire life cycle. From strategy and regulatory submissions through post market surveillance, A Wright Path® is with you every step of the way. The Right Intelligence. The Right Experience. The Right Strategy. The Right Path...
See how we’ve brought our Partners Success
With strong and solid industry expertise, A Wright Path® navigates and executes the FDA & global regulatory requirements from design to approval so our clients can achieve the launch of their products with confidence into the marketplace.
Meet Our Path Leaders
Latest News and Events
As a new medical device start up, the process of making your product compliant might seem daunting, but it doesn’t have to be. The experts in the field have some solid advice for getting on the right path. “A key piece of advice would be to have a strong regulatory strategy from the beginning as […]
Today, the FDA issued final guidance on Medical Device Reporting for Manufacturers. This guidance document is intended to assist medical device manufacturers meet applicable reporting and recordkeeping requirements for certain device-related adverse events and malfunctions. There have been numerous changes to the medical device reporting requirements since the FD&C Act first described them and the Medical […]
Today the FDA launched a webpage on Allegations of Regulatory Misconduct, which are claims that a medical device manufacturer or individuals marketing medical devices may be doing so in a manner that violates the law. The website explains the process for submitting allegations to the Center for Devices and Radiological Health (CDRH) and contains a form to […]