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.

Get the Industry 4.0 and Medical Devices Whitepaper

Fill out the form below, and the webinar will get sent directly to your inbox.
Govind Yatnalkar

Govind Yatnalkar

More Resources

Abbreviated 510k submission

Abbreviated 510k submission

There are three types of 510K, Premarket Notifications, which can be submitted to the Food and Drug Administration (FDA) traditional, abbreviated, and special. Abbreviated and Special 510K submissions can be utilized when the submissions meet the certain factors presented by the FDA. When submitting an abbreviated 510K the submission must include the elements that are identified in 21CFR 807.87 for the information required in a premarket notification submission.
Is your product a medical device?

Is your product a medical device?

Many marketed products are classified as medical devices and you would not even know it. Medical devices range from latex gloves and tongue depressors to respirators and heart valves. To determine if the product is considered a medical device by the Food and Drug Administration (FDA) you will need to analyze if your product meets the definition of a medical device per the Food, Drug, and Cosmetic Act1.
Sterilization of Medical Devices

Sterilization of Medical Devices

There are many ways to sterilize medical devices before use in the industry. The common methods utilized are steam, radiation, dry heat, ethylene oxide, and vaporized hydrogen peroxide. There are two methods of sterilization for medical devices recognized by the Food and Drug Administration (FDA), established and novel.

Ready to learn more about working with us?

Pin It on Pinterest

Share This