Industry 4.0 and Medical Devices

by | Feb 26, 2021 | Uncategorized

As we progress through the 4th Industrial Revolution, technology is advancing quicker and quicker. More and more medical devices are being developed using AI/ML, Cloud Computing, and Internet of Things (IOT). This technology in the life sciences domain is uncharted, leaving a regulatory gap that the FDA is diligently working to close. The purpose of this white paper is to discuss the quality and regulatory approach for medical devices and software tools that contain AI/ML-based software. Along with the regulatory approach, our secondary motive is to explore a case study for developing a Next Generation (NGen) eQMS. The case study focuses on how an eQMS could be integrated with modern technologies to deliver a full-fledged software product. We also discuss the standard software validation principles that describe what activities manufacturers should implement to ensure their software is compliant with the required regulations, regardless of if it is a medical device or a tool used to develop a device like an eQMS.

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Govind Yatnalkar

Govind Yatnalkar

More Resources

Process Validation

Process Validation

All right, you have just gotten all of your paperwork together, submitted the right forms to the right people, set up your factory, hired and trained your staff; now it’s time to make the medical devices. The regulatory nonsense is over and done, right?
The Role of Management in Product Quality

The Role of Management in Product Quality

Depending on the factory, some production employees may find it surprising that management has an important role to play in a quality system.  21 CFR 820.20 mandates that “Management with executive responsibility shall establish objectives for, and commitment to, quality”.[1]  The Federal Government expects that management takes an active interest in improving the output of their company, at least in the case of medical device manufacturers.
Corrective and Preventive Action

Corrective and Preventive Action

In addition to helping manufacturers make better products, corrective and preventive actions are important because the process is legally required by the FDA when making medical devices for the US market.

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