FDA Regulatory Consulting

For those in the early stages of product development, our team provides strategic guidance to lay a solid regulatory foundation. We understand the unique regulatory challenges of software and leverage our deep industry knowledge to craft bespoke strategies that streamline the path to compliance.

This service may be relevant for you if you’re asking any of the following:

• Is my product a medical device?
• Will adding certain functionality make our product qualify as a medical device?
• What is the fastest way to get your device onto the market?
• What are the costs and timelines involved brining a medical device to market?
• Our team has experience with hardware devices, but we’re adding software or AI/ML features to our product line.
• Which features should we include in our device first? How will certain features affect the regulatory strategy?
• We sell our device in Europe already. How can we sell it in the US?
• Our product didn’t used to be a device, but the FDA is regulating it—what do we do?

Engaging with the FDA early and effectively is crucial for a smooth regulatory process. We facilitate and manage pre-submission meetings, helping you to clarify and address potential regulatory issues before formal submission.

Navigating the 510(k) submission process can be daunting. Our consultants are adept at reviewing and preparing submissions, ensuring that all documentation meets the FDA's rigorous standards.

We provide two services related to 510(k) submissions, depending on your team’s experience and needs.

• Our Guided 510(k) Service is for teams who can use support, examples, and review of their 510(k), but generally plan to do most of the documentation work themselves.
• Our Fast 510(k) Service is for teams who are in a hurry and see the benefit of shaving off months from their timeline for a premium cost. This is our most unique service offering and it hinges on our combined software and regulatory expertise. We guarantee the results and timeline.

In the event of additional information requests from regulatory authorities, our team stands ready to assist even if we weren’t involved with the submission. Our Additional Information Request Response Service provides timely and expert support in interpreting and responding to AI Requests, ensuring timely and satisfactory resolutions that keep your project moving forward seamlessly.

We partner with existing regulatory teams to enhance their capabilities, especially in areas where software intersects with medical device regulation. Our experts can fill knowledge gaps around cybersecurity or AI/ML-specific guidance and FDA expectations.

• De Novo Classification Requests
• STEP / Breakthrough Device Designations
• Predetermined Change Control Plans (PCCP)
• 513(g) Classification Requests
• Second-Opinion US FDA Software Document Review
• Second-Opinion US FDA Entire 510(k) against FDA regulations and guidance
• Gap assessment of a QMS against IEC 62304, ISO 14971, or ISO 13485
• Ongoing Post-Market Regulatory Support
• Internal & Supplier Audits
• Mock FDA Inspections
• FDA Warning Letter Responses

Absolutely! We frequently consult with in house teams on topics related to software, cybersecurity, and AI/ML.

Unfortunately, no. Although most of our team members have experience with CE marking, Health Canada, UKCA, and other regulatory submissions—we’ve decided to focus just on the US market so that we can be experts in this jurisdiction.

We have partners we can coordinate with for international regulatory consulting.

Unfortunately, no. Although several of our team members have experience hardware-only devices, we’ve decided to specialize in software-enabled medical devices.

We have partners we can introduce you to for hardware-only devices.