At Innolitics, we specialize in navigating the complex landscape of regulatory compliance for Software as a Medical Device (SaMD). Our team brings a wealth of experience in the U.S. FDA’s software, AI/ML, and cybersecurity regulations and guidance. We also have experience with the new and evolving Predetermined Change Control Plans (PCCPs). We are dedicated to ensuring that your medical devices not only meet regulatory standards but also incorporate the cutting-edge security and functionality that today's healthcare landscape demands.
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:
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.
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.
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.
Every great partnership starts with a conversation. Fill out the form below for a discovery call, and an Innolitics team member will contact you soon.