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The U.S. Food and Drug Administration (FDA) requires different regulatory requirements for medical devices and combination products before bringing the product to market. FDA-regulated products must follow the correct regulatory pathway toward approval, which may include pre-submission requests, pre-market notifications or pre-market approval, meeting Good Manufacturing Practices (GMP), FDA registrations, FDA inspection, labeling requirements including UDI, and post-market surveillance.  

Medical device companies should be able to focus on product development without worrying about hurdles on their road toward regulatory compliance — in steps the FDA consulting firm, A Wright Path!

By choosing us, you will benefit from a strong foundation built on industry experience combined with a dedicated passion for helping our clients and ensuring safe products. You will avoid costly delays and regulatory hurdles in your product launch and move through regulatory processes with maximum efficiency.

With our regulatory consulting services, we’ll review your medical product to find the best regulatory path for you to meet all regulatory requirements — to both gain approval and maintain it. After all regulatory submissions and assessments are complete, we can also help maintain your status in the long term. Our services also include Quality Management Systems (QMS) development with effective standard operating procedures (SOPs), maintaining Good Manufacturing Practices (GMP) and QMS, FDA and ISO 13485 internal audits, FDA inspection and Regulatory Agency support, technical services (biocompatibility, sterilization, and packaging), remediation activities following warning letters, Clinical Trial Strategy and Support, and more!

We are committed to making every client satisfied with their choice to take A Wright Path. Schedule a consultation today!

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Start on the Right Regulatory Path, Right Now!