Frequently Asked Questions (FAQs)

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.

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.

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

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.

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

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

1. ISO 13485 is the international standard for medical device quality management systems (QMS). 2. It ensures regulatory compliance, risk management, and process control for device manufacturers.

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

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