My product is Class I, do I still need a Quality System?

FDA classifies medical devices according to the level of control necessary to assure their safety and effectiveness. There are 3 classes of medical device, with Class I requiring minimal controls and Class III requiring the highest level of control. 

If you know you’re a Class I product, Congrats! You have a much regulatory burden…since your product is designated as low risk, you are likely exempt from premarket notification requirements (meaning you don’t have to submit anything to the FDA to sell the product).

*However* most Class I and Class II devices are still required to comply with good manufacturing practices (GMP) and the quality system regulations (as specified under 21 CFR Part 820). 

To determine if your product is required to comply with these requirements, you need to determine if your device falls under an existing FDA product code. From there you can figure out how complicated of a quality system you need to set up. Even devices that are exempt from the QS regulations are still required to comply with “general controls” - these are the controls required for all products under the FDA’s jurisdiction, and includes things like complaint handling and record keeping. 

Need some help identifying your product code and figuring out if you need a quality system or how “big” of a quality system to set up? 

Schedule a free consultation using the calendar link below to get your questions answered.

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What’s a Rich Text element?

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

What’s a Rich Text element?

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

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What’s a Rich Text element?

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

What’s a Rich Text element?

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

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What’s a Rich Text element?
The rich text element allows you to create and format headings, paragraphs, blockquotes, images, and video all in one place instead of having to add and format them individually. Just double-click and easily create content.

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A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

How to customize formatting for each rich text

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Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.

The Nemedio Blog:  Demystifying Compliance

your guide to product development and compliance for medical technology
FAQ

My product is Class I, do I still need a Quality System?

April 21, 2022

FDA classifies medical devices according to the level of control necessary to assure their safety and effectiveness. There are 3 classes of medical device, with Class I requiring minimal controls and Class III requiring the highest level of control. 

If you know you’re a Class I product, Congrats! You have a much regulatory burden…since your product is designated as low risk, you are likely exempt from premarket notification requirements (meaning you don’t have to submit anything to the FDA to sell the product).

*However* most Class I and Class II devices are still required to comply with good manufacturing practices (GMP) and the quality system regulations (as specified under 21 CFR Part 820). 

To determine if your product is required to comply with these requirements, you need to determine if your device falls under an existing FDA product code. From there you can figure out how complicated of a quality system you need to set up. Even devices that are exempt from the QS regulations are still required to comply with “general controls” - these are the controls required for all products under the FDA’s jurisdiction, and includes things like complaint handling and record keeping. 

Need some help identifying your product code and figuring out if you need a quality system or how “big” of a quality system to set up? 

Schedule a free consultation using the calendar link below to get your questions answered.

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