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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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#MedicalDeviceAcademy - We finally selected our logo contest winner for the new Las Vegas 510(k) workshop (http://medicaldeviceacademy.com/las-vegas-510k-workshop). Thank you to everyone that voted on our polls.
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#MedicalDeviceAcademy - Please vote on which logo you like best for the 510(k) workshop in Las Vegas and Amsterdam.

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#MedicalDeviceAcademy is working with 99 Designs to create a logo for our Amsterdam 510(k) workshop on March 21-22, 2018. Your feedback on the top two logos would be appreciated by me and the designers.

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Can't wait to see the new logo for our Las Vegas 510(k) workshop!

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#MedicalDeviceAcademy - What do you do when you have to re-submit your FDA eCopy 3x in one week for three different submissions? That's 9 submissions in one week.

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#MedicalDeviceAcademy - The Amsterdam 510(k) workshop was a success, and now we begin preparations for the Las Vegas 510(k) workshop in March 2018.

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#MedicalDeviceAcademy - new video posted announcing the Amsterdam 510(k) workshop on October 11-12, 2017.

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#MedicalDeviceAcademy - What are the strategic implications of changes to the FDA user fees for FY 2018?

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http://medicaldeviceacademy.com/510k-design-control/ - Mary Vater's article explains which elements of your DHF and risk management file need to be included in your 510(k) submission.

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#MedicalDeviceAcademy - A 2-day workshop on 510(k) submissions is being hosted by Factory-CRO and Medical Device Academy in Amsterdam on October 11-12, 2017. Please follow the link for more details regarding the location, speakers and topics covered. The speakers will also be offering free webinars in the next few months related to 510(k) submissions. There is an information brochure you can download directly from the webpage. You can also save $600 on registration if you register for the workshop on or before July 10.
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