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Product Development

CDRH Proposed Guidance for FY 2023

December 21, 2022
What are the proposed CRDH guidelines for the 2023 fiscal year, and why do they matter? How should you be thinking about them? Read More
Product Development

Design Controls Need to Start With User Needs

December 19, 2022
In the FDA’s classic design control waterfall diagram, the box at the left-hand top of the waterfall is labeled “user needs.” Read More
Product Development

The Importance of Management Reviews for CAPAs

December 18, 2022
The corrective and preventive action process is a cornerstone to a healthy QMS, and provides oversights, insights, and checks and balances for nonconforming products and... Read More
Product Development

CAPA Best Practices: 4 Tips for Building an Excellent CAPA Process

December 16, 2022
An effective CAPA process is one of the most important parts of your quality management system (QMS). It’s your tool for addressing systemic or highly critical issues in your... Read More
Product Development

Future of the Emergency Use Authorization (EUA): COVID, Monkeypox & Beyond

December 14, 2022
EUAs were less known before COVID than they are now. Between COVID and now Monkeypox, what has been learned about EUA, and where is it going as we move forward? Those are... Read More
Product Development

The Future of Healthcare & How We Get There

December 7, 2022
What kinds of possibilities exist in the future for healthcare? How can medical devices reach across different fields of medicine and provide a holistic patient experience in... Read More
Product Development

The Difference Between Intended Use and Indications of Use (And Why These Statements Are So Important)

December 2, 2022
“Intended use” and “indications for use” are two of the easiest terms to confuse in the medical device industry. They’re often used interchangeably, not only because they... Read More
Product Development

Nonconformance (NC) and CAPA: When Should You Use Each Process?

December 2, 2022
Your nonconformance (NC) and Corrective Action and Preventive Action (CAPA) processes are two critical elements within your quality management system. Read More
Product Development

What "Exempt" Means with Respect to Medical Devices & Regulatory

November 30, 2022
How should you be thinking about 510(k) exemptions for medical devices? Do you know when things do and don’t qualify for exemption and how that intersects with how a device... Read More

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