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 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:

  • Medical Devices
  • Dental Laboratories
  • Combination Products
    (Device, Drug, Biologic)
  • Consumer Product Industries
    (including Cosmetics and Children’s Products)

How We Help

We see your product through its entire life cycle. From strategy and regulatory submissions through post-marketing surveillance, A Wright Path® is with you every step of the way. The Right Intelligence. The Right Experience. The Right Strategy. The Right Path...

A Wright Path areas of expertise

Learn how to get on the Wright Path!

Watch our video to learn how to get your company on the Right Regulatory Path, Right Now!

What We Offer

REGULATORY AFFAIRS

We offer the Right Path, Right Now® to expedite your products faster to the global marketplace with maximum regulatory efficiency to avoid regulatory hurdles.

QUALITY MANAGEMENT SYSTEMS (QMS)

We offer the Right Path, Right Now® to develop, implement and sustain your Quality Management System for compliance to global regulatory requirements.

DESIGN QUALITY ASSURANCE

We offer the Right Path, Right Now® to define global regulatory and customer requirements to ensure compliant products and patient safety.

QUALITY ASSURANCE

We offer the Right Path, Right Now® to ensure all the planned and systematic activities are implemented within the quality management system to provide confidence in a quality product or service.

POST MARKET SURVEILLANCE (PMS)

We offer the Right Path, Right Now® to ensure a collection of processes and activities to monitor the performance of a product.

REMEDIATION ACTIVITIES

We offer the Right Path, Right Now® to ensure a quality plan to define remediation activities, root causes, and corrective actions as well as risk during remediation activity.

CONTINUOUS IMPROVEMENT

We offer the Right Path, Right Now® to reduce waste, increase efficiency, and improve internal employee and external customer satisfaction.

SAFETY

We offer the Right Path, Right Now® to develop and implement policies, ensuring that procedures are in place for the safety and health of employees within a workplace.

See all of our Services

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, enabling our clients to confidently launch their products into the marketplace.

Meet Our Path Leaders

Meet some of our Consultants

Latest News and Events

Advice from Experts on Getting Your Start Up Medical Device on the Path to Success

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 […]

FDA announces final guidance and upcoming webinar on Medical Device Reporting for Manufacturers

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 […]

CDRH Industry: The FDA Launches New Webpage for Reporting Allegations of Regulatory Misconduct

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 […]

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402 Lytham Court Suite 101 Moon Township, PA 15108
844-297-7284

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Are you ready to get on the Wright Path?

Contact us today to Partner with A Wright Path®, we are ready to get you on the Right Regulatory Path, Right Now!