Question 1

How do regulatory processes compare across different markets?

Accepted Answer

For companies operating across multiple markets, understanding regulatory divergence is essential.

Our traffic-light comparison table outlines key areas where regulatory requirements differ significantly between jurisdictions.

Question 2

What are the main concerns in the regulatory process for AI-enabled (ML) Systems?

Accepted Answer

1. Change Management is the biggest concern, as Machine Learning models do not remain static once deployed. 
2. A Predetermined Change Control Plan (PCCP) is therefore essential for documenting anticipated changes and associated risks. 
3. Regulators are increasingly prioritizing developers’ quality systems over individual product reviews.

Question 3

What are some of the biggest risks that regulatory agencies are looking for in premarket product reviews?

Accepted Answer

If the data support the marketing claims for safety, efficacy and quality. How the device performs: Is it easy to use and durable?

Question 4

When should we consider the regulatory process as we develop our MVP?

Accepted Answer

From the ideation phase, consider using clinical evidence if there is a claim to diagnose, treat, or prevent a medical condition.  Data must support your marketing claim.

Question 5

What is the biggest difference in regulating therapeutics vs. Medical Devices?

Accepted Answer

Overall, the process is similar; however, medical devices typically undergo three development stages, while pharmaceuticals follow a four-phase clinical development pathway.

Question 6

How should we choose the type of clinical trial to use for a new product?

Accepted Answer

1. Consider the specific study goals: Will the device (MD) be:
 As good as the standard of care?
Have significantly higher benefits? 
Have 2 endpoints to demonstrate a combination of both? 
2. Consider the nature of the medical device being evaluated

Question 7

Why is ISO 13485 important?

Accepted Answer

ISO 13485 is the international standard for medical device quality management systems       (QMS). 
It ensures regulatory compliance, risk management, and process control for device       manufacturers.

Question 8

What are the key requirements for CE marking in the EU

Accepted Answer

CE marking in the EU requires compliance with the Medical Device Regulation (MDR) and       certification from a notified body. It has several key elements.

Question 9

Can software be used as a Medical Device?

Accepted Answer

Yes, if the Intended use is for one or more medical purposes and it operates independently of hardware to achieve  that purpose.

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