Navigating The FDA/CE Mark Process

"By no means should you compromise safety qualities because you are developing products for a different market...investing the time and money into developing a robust process early on is something that is required for all medical device companies." ~ Sona Shah

This is the first episode of a three-part series on Medical Device Regulation: Navigating the FDA/CE mark regulatory process. 

In this episode, we host Sona Shah, founder and CEO of Neopenda. Neopenda is a medical device company focused on designing and implementing use-base technologies for emerging markets. Their remote vital signs monitor reduces the burden of clinicians and helps them monitor more patients efficiently while reducing the risks of infection.

Sona Shah gives us insights into how they navigated the regulatory process for their medical devices in the USA and East Africa, the challenges they faced, and how MedTech devices can go about getting regulatory approvals for their products. 

Should companies prioritize regulatory approvals and at what stage?

- Quality management is essential - setting up a robust quality management system early on will give you an understanding of how to approach document controls and revision history. It is also important to Invest in this early on and understand the standards you will have to adhere to from a regulatory perspective.

- Getting feedback from your users during your iterations and understanding how to document that is key during the early stage. You may want to go through the regulatory approvals once you have a more defined product.

How can companies minimize expenses while maximizing regulatory outcomes?

- Consultants - Regulatory consultants are essential because they understand the nuances of the documentation of the regulatory process. It is important to establish the QMS with them and once you have that set up, you follow the laid down process. As you are starting to finalize your product, I would recommend bringing on a consultant, as it will save you the time and money you may have to spend redoing your product.

- Even if you are applying for local regulation, I would recommend you understand the FDA/CE Mark process well because it can be a lot of work to go from local registration to stringent authorities like FDA/CE Mark. Design for submission to FDA/CE Mark during your process, as this is typically sufficient for local registration.

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