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Robert Packard
Regulatory consultant specializing in CE Marking of Medical Devices and ISO 13485 Certification
Regulatory consultant specializing in CE Marking of Medical Devices and ISO 13485 Certification
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https://fdaecopy.com/design-changes/ - Can you submit a design change after 510(k) submission, but before the 510(k) clearance letter has been issued? This article summarizes the primary issues related to design changes during the 510(k) process.

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There are four possible root causes for receiving an NSE letter. Corrections are different for every new device, but there is one corrective action to avoid another NSE letter for your 510(k) resubmission.

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I'm really excited to return to San Francisco for another 510(k) workshop. It's been about a year and a half since the last one. This year the curriculum is totally redesigned, there will be exercises where you create documents for your next submission, you will get an entire set of 510(k) templates, you get a new book titled "How to prepare your 510(k) in 100 days," and there are a lot of great lessons learned to share from dozens of submissions we have worked on since 2015.

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Can you submit an abbreviated-type 510(k) or do you need to submit a traditional 510(k)? Read this to learn how to verify which is required.

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#MedicalDeviceAcademy provides links to adverse event databases used to gather post-market surveillance data.

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#MedicalDeviceAcademy - Typically procedures get longer when we revise and update them. This article explains how a training procedure was reduced by half when we updated the procedure for compliance with ISO 13485:2016.

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#MedicalDeviceAcademy - review of information available on the FDA eCopy website to help you submit your own FDA eCopy.

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#MedicalDeviceAcademy - New article about FDA pre-submission meeting request feedback options. The article helps you to decide which method of feedback you should use for your next pre-sub request: 1) face-to-face meeting, 2) teleconference, or 3) email.

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#MedicalDeviceAcademy posted a new article providing an overview of the changes to requirements for clinical evaluation reports in MEDDEV 2.7/1 rev 4. There is also a new webinar and procedure that is available. Links to the procedure and webinar page are provided in the article.

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#MedicalDeviceAcademy announced three new, one-day 510(k) workshops. The cities are: San Diego (March 7), San Francisco (March 8) and Chicago (April 18). The cost is $774/person.
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