The 9 Steps To Get medical Certification For Your Biomedical Product
From drugs to device, AI, and robotics
This week Paradromics gets one step closer to FDA approval for its brain implant. And Neuralink even got the approval for human study of brain implants by FDA. While it is obvious why an invasive device touching the brain requires certification, it is not clear to many people that even other unsuspected devices (such as a thermometer) also require certification. With the plethora of tools for AI-based diagnostics in those years, validations are required, also because what is hype on social media, news, and research not necessarily it is translated overnight in clinics.
Medical devices are not like any other product, most often they require specific certification to be accredited in the market. Although, in some cases, devices without certification are used upon clear disclaimer and agreement of the lack of certification.
For a young startup with limited funding, this might be a temporary solution. They launch “a research product” which is used nevertheless, and in the meantime, they start the process of proper certification. Obviously, the lack of certification can reduce drastically the number of investors, clinical partners, and customers, but it can be a start.
