Regulatory guidance that alleviates your strategic and operational needs with forward-thinking, compliant and sustainable solutions.
get startedWe help evaluate your product and provide clear information as to whether or not it would be considered a medical device, and if so then what product classification, review pathway, and potential data necessary to satisfy the FDA review process - or any other health authority.
Do you have a novel technology? Or a product that is more effective than what’s currently on the market? We can help you understand the requirements and prepare your Breakthrough Device Request.
Whether you know you need a 510k or a De Novo request, we can help you strategize, plan, prepare, and submit your applications.
In some cases it might be beneficial to have formal communication with the FDA about your product submission. We can help you plan, prepare and submit your Pre-sub so you can avoid common pitfalls and receive direct and valuable feedback from the FDA.
What is an FDA Pre-Sub?
Artificial intelligence (AI) and machine learning (ML) technologies have increasingly helped manufacturers innovate their products to better assist health care providers and improve patient care.
We help you navigate the regulatory nuances of making modifications and adaptations to your software to ensure the safety and effectiveness of the software as a medical device is maintained.
General wellness devices have become increasingly more popular and include devices like smart watches, exercise equipment and mobile health apps which are intended to promote a healthy lifestyle. It is important for companies to understand how and when their technology could encounter FDA scrutiny.
We help you understand these risks and identify a clear product path for your device, while ensuring that your product remains within the general wellness device guidelines.
Medical devices are increasingly connected to the internet, hospital networks and other medical devices to deliver features that help healthcare providers deliver and improve patient treatments, which can pose a risk of encountering security breaches. We help you mitigate cybersecurity risks, understand the guidances and safety communication standards to appropriately prepare you in the case that your medical device encounters security breaches that could potentially impact the safety and effectiveness of the device.
Whether you are in ideation stages or further along in your development, we can help simplify the regulatory landscape for your device and get you where you want to be.
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