You have an idea for a new medical device (maybe even a prototype). You’ve heard of words like “compliance,” “quality management,” and “regulatory affairs,” but you aren’t quite sure what they mean, and how or when to get started on implementing them at your company. During this talk, we will shed light on these and other compliance concepts. We will also provide you with a set of compliance activities that are appropriate for early stage companies, which will set you up for success as you transition to a full-blown compliance program when the timing is right for your company.
Learning Objectives
After this session, attendees should understand:
FDA device classification
Paths to FDA clearance
Quality management and quality management systems
How and why agile development teams can and should start quality and regulatory activities earlier than they think
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.
You have an idea for a new medical device (maybe even a prototype). You’ve heard of words like “compliance,” “quality management,” and “regulatory affairs,” but you aren’t quite sure what they mean, and how or when to get started on implementing them at your company. During this talk, we will shed light on these and other compliance concepts. We will also provide you with a set of compliance activities that are appropriate for early stage companies, which will set you up for success as you transition to a full-blown compliance program when the timing is right for your company.
Learning Objectives
After this session, attendees should understand:
FDA device classification
Paths to FDA clearance
Quality management and quality management systems
How and why agile development teams can and should start quality and regulatory activities earlier than they think
Hosts
Sabrina Varanelli, CEO
Sam Barberie, VP of Sales & Partnerships
Gilly Yildirim, Senior Project & Accounts Manager
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