What We Do As Your Regulatory Strategy Partner

At A Wright Path®, we view our clients as our business partners and work with you to develop the regulatory pathway that will best benefit your business. Our partnership is built on excellence, integrity, passion, and social conscience. As your business partner, we will stay ahead of today’s quickly changing regulatory requirements to take your business into the future. We’ll be your partner for determining your medical device or combination product regulatory strategy.


We are committed to making sure every client is satisfied with their decision to choose A Wright Path®. It is our mission to serve our clients and their patients at the highest possible level through consistency, attention to detail, exceptional communication, maximum efficiency, and a commitment to both the client experience and results. Our client relationships are guided by these five principles:

  • Partnership — We value our relationships with each other, our client-partners, and our community. Our goal is a mutually beneficial interaction with all parties.
  • Excellence — We continually push ourselves beyond our limits in pursuit of the highest standards in our industry.
  • Integrity — We weigh our actions honestly and take responsibility for them, regardless of the consequences. We maintain all our values with a sense of duty.
  • Passion — We take inspired action for our client-partners and their patients because we truly care about the well-being of both.
  • Social Conscience — Not only do we always do the right thing, but we proactively seek ways to have a positive impact on all of our relationships.

Our services

With strong and solid industry expertise, A Wright Path® navigates and executes the Food and Drug Administration (FDA) & global market’s regulatory requirements from the product development process to commercialization, enabling our clients to confidently launch their products into the healthcare marketplace.

As your partner, we’ll work with you to identify and prepare your regulatory strategy for the market you intend to enter and if required, prepare and submit regulatory submission to regulatory agencies. We offer support in device classification, pre-submission guidance, premarket approval (PMA), premarket notifications (501k), Clinical Trial & Strategy throughout your regulatory pathway. But our services don’t stop there! Maintain regulatory compliance with our quality management services. Learn more about how we can help your medical device regulatory strategy from conception to market commercialization.


Regulatory Affairs

Expedite your product development and hit the global marketplace with maximum regulatory compliance in FDA Regulatory Submissions, CE Marking, and more — while avoiding hurdles.

Quality Management System

As your partner, we’ll help develop, implement and maintain your Quality Management System (QMS) to meet FDA, Medical Device Directive (MDD),  Medical Device Regulation (MDR), MDSAP, ISO 13485, ISO 14971, and ISO 9001 regulatory requirements.

Design Quality Assurance

As a partner, we’ll help ensure compliant products and patient safety with risk management for existing devices, new devices and combination products (devices/drugs/biologics).

Quality Assurance

We’ll work with you to implement your quality management system to maintain regulatory compliance and sustain product quality.

Post Market Surveillance

After market approval, we offer activities to set up a post market surveillance plan to collect and evaluate post market performance and safety.

Remediation Activities

Regulatory submissions are just the beginning. We’ll work with you to formulate a plan following an internal/external audit or Regulatory Body inspection to determine root cause, corrective actions, and risk management of future regulatory issues.