For FDA approval, what certification do you need when you use NMS4110 as part of a medical device?

NEMESIS’ NMS4110 is a low-power, high-performance electrochemical read-out IC. However, NMS4110 itself does not typically achieve FDA approval directly because FDA approvals are usually granted to complete medical devices, not individual components like ROICs.

Manufacturers who use the NMS4110 in a medical device might seek FDA approval for their end product, which may involve demonstrating that the device meets all necessary regulatory standards, including safety, accuracy, and reliability. In this context, the NMS4110 would be a critical part of the system that is validated as part of the overall product’s performance.

If you are seeking certifications related to specific medical device standards (such as ISO13485 or IEC60601 for electrical safety), NMS4110 may be part of products that comply with these standards, but it itself would not receive such certification.

• ISO13485: Quality management system standards for medical devices, Manufacturers need to show that they have a robust process for managing the supply chain, including components like the AD5940, to ensure consistency and safety

• IEC 60601-1: Medical electrical equipment safety standards, Testing to this standard ensures that components used in the device do not introduce unacceptable risks.

• ISO14971: Medical device risk management standards, which require that potential hazards from components like NMS4110 be identified and mitigated

How do you ensure that NMS4110 meets FDA’s regulatory standards including safety, quality, and risk management when it is a part of medical device during a FDA approval process?

As a component like the NMS4110 is used in a medical device, it doesn’t require to achieve FDA approval directly, here’s how you can demonstrate that the NMS4110 meets these standards during the FDA approval process.

1. Component qualification and validation

• Component selection and data: Manufacturers must show that the NMS4110 is a suitable component for the medical device. This includes providing technical specifications, performance data, and reliability metrics from NEMESIS. For example, data sheets, white papers, and reliability reports from NEMESIS can be used to demonstrate the component’s capabilities.

• Internal Testing: The device manufacturer typically conducts verification and validation tests to ensure that the NMS4110 meets the intended functionality and performance requirements within the context of the medical device. This includes testing the accuracy of measurements. (e.g., electrochemical sensing) and ensuring the stability of readings under different conditions (e.g., temperature, noise, and power variations).

2. System-Level Testing

• Risk Management: The manufacturer must assess risks at the system level, where the NMS4110 is integrated into the overall device. This includes conducting Failure Modes and Effects Analysis (FMEA) and addressing potential risks such as signal integrity issues, electromagnetic interference, and power management concerns.

• System Validation: FDA expects that the medical device undergoes design validation to ensure that it meets user needs and intended uses. The NMS4110’s role in the system’s performance (i.e., providing accurate sensor data) must be validated through clinical testing or simulated use cases.

3. Standards Compliance

The NMS4110, as a part of the larger medical device, needs to comply with relevant regulatory standards such as:

• IEC60601-1: Medical electrical equipment safety standards. Testing to this standard ensures that components used in the device do not introduce unacceptable risks.

• ISO13485: Quality management system standards for medical devices. Manufacturers need to show that they have a robust process for managing the supply chain, including components like the NMS4110, to ensure consistency and safety

• ISO14971: Medical device risk management standards, which require that potential hazards from components like NMS4110 be identified and mitigated

• Component Traceability: Documentation showing the traceability of the AD5940 throughout