US Regulatory Consulting

We are US Regulatory experts who specialize in medical-device software and cybersecurity. We’ve helped over 50 medical-device companies achieve regulatory clearance.

Whether you are looking for a full-service regulatory partner or specialized consulting, we can help.

Our Specialized Services

Regulatory Strategy and Pre-Subs

For those in the early stages of product development, our team provides strategic guidance to lay a solid regulatory foundation. We understand the unique challenges of SaMD 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.

510(k) Submissions

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.

Requests for Additional Information

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.

Consultation for In-House Teams

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.

Other Services

We can act as a full US FDA regulatory partner and can handle a variety of less common situations:

• De Novo Classification Requests
• STEP / Breakthrough Device Designations
• 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

Why Choose Us?

• Expertise in Software and Cybersecurity: Our team's proficiency in software engineering, AI/ML, and cybersecurity is unparalleled. We not only understand the technical nuances of SaMD but also how to integrate these advancements within a regulatory framework.
• Bridging the Gap Between Engineering and Regulation: We excel in translating complex regulatory requirements into actionable guidance for engineers. This reduces friction, expedites development, and ensures that your engineering team can focus on what they do best.
• Efficiency in Documentation and Compliance: Our approach to documentation strikes the perfect balance between thoroughness and efficiency. We prioritize the most impactful areas, ensuring compliance without unnecessary overhead, thereby accelerating your time to market.
• Future-Proofing Your Processes: Our consultancy goes beyond immediate regulatory needs. We help integrate compliance into your automated software development processes, making regulatory adherence a natural part of your workflow and setting you up for long-term success.

At Innolitics, we understand that regulatory compliance is more than a hurdle; it's an integral part of delivering safe, effective, and cutting-edge medical devices. Let us be your partner in this journey, ensuring that your products not only meet the current standards but are also poised to adapt to the evolving regulatory landscape. Contact us today to learn how we can tailor our services to meet your unique needs.

Top Regulatory Resources

Here are a few of the many articles we published on US FDA regulatory topics: