6 Preliminary Questions Around FDA’s RTA Policy for 510(k)
Outlining the Preliminary Qualifications and Evaluation of FDA’s Updated RTA Policy for 510(k) Submissions
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8 Regulatory Strategy Guidelines for Your Medical Device
Learn how your company can form a Regulatory Strategy in 8 easy steps.
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5 Steps to Obtain a CE Marking on Your Medical Device
How to utilize ISO 13485 to acquire a CE Marking on your Medical Device.
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What are CAPAs?
Learn the purpose of Corrective and Preventive Actions (CAPAs) for Medical Device Development.
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How to Create Successful SOPs for your Medical Device
Explore the key considerations for Standard Operating Procedures (SOPs) for Medical Device Companies
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What are Standard Operating Procedures (SOPs)?
Defining SOP’s as they pertain to your Medical Device.
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What is FDA's 21 CFR Part 820?
Unpacking the FDA guidelines and regulations under 21 CFR Part 820.
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A Regulatory Approach Manual for Device Software Functions
Understanding the policies for your Medical Device Software Functions
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