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Robert Packard
Worked at Medical Device Academy
Attended University of Connecticut
Lives in Vermont
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Robert Packard

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#MedicalDeviceAcademy  How do you remove an unintended hidden system file from an ecopy for an FDA submission?
article explains how to fix a 510k submission ecopy on a USB flash drive including debugging problems created by the most recent Windows 10 update
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Robert Packard

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#MedicalDeviceAcademy  just published an article reviewing the minimum number of data points needed in order to trigger a CAPA. The answer is almost never 3.
article explains why three is never the right answer article explains why asking how minimum data points are needed to identify a trend
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Great and clear overview. Cheers!
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Robert Packard

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#MedicalDeviceAcademy  published a new article explaining why clnical evaluation reports are required for Class 1 devices and how to go about gathering clinical study information on even Class 1 devices.
how to write a clinical evaluation report (CER) for CE Marking Class 1 medical devices when there is little or no clinical study literature available
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Robert Packard

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New live webinar on creating a design history file (DHF) in accordance with 21 CFR 820.30j and the updated ISO 13485:2016 Standard.
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#MedicalDeviceAcdemy  published a new article about how to prioritize your FDA Form 483 responses when you have multiple inspection observations.
Article explains how to determine which FDA Form 483 response you should write a corrective action plan for first and why.
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#MedicalDeviceAcademy  posted a new article about De Novo applications for medical device submissions to the FDA.
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#MedicalDeviceAcademy  published an article explaining how to search for a special controls guidance document and what the typical format and content is for these guidance documents.
article explains content and format of a special controls guidance document issued for Class 2 medical devices regulated by the CDRH division of the US FDA.
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#MedicalDeviceAcademy  - How do you control design changes? Do you use the same process for changes implemented prior to design freeze that you use during design transfer? Best practices is to use a risk-based approach.
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#MedicalDeviceAcademy  published a new article explaining why your DHF content should be based upon your design plan rather than a DHF template.
The article does not include a DHF template, but recommendations for format and content of a design history file are provided.
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Robert Packard

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#MedicalDeviceAcademy  - Announcing a new live webinar next Thursday, April 14 on the topic of Design History Files (DHF). It will start at 10am EDT.
I recently had a couple of clients request a quotation for training on best practices for creating a design history file (DHF). Typically the most experienced quality managers request this training, even when they personally know a lot about design controls, because they know that the FDA issues ...
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http://medicaldeviceevents.com/#schedule - Are you attending the workshops on 510(k) submissions and CE Marking for May 2. $325/workshop. Last year's workshop on 510(k) submissions was sold out with standing room only.
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#MedicalDeviceAcademy  published a new article yesterday summarizing the content of the newest FDA guidance on human factors engineering and usability engineering.
Yesterday, February 3, the FDA released a new guidance document on the subject of “Applying Human Factors and Usability Engineering to Medical Devices.”
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Tagline
Regulatory consultant specializing in CE Marking of Medical Devices and ISO 13485 Certification
Introduction
Hello! I'm a regulatory consultant with 20 years experience in the medical device, pharmaceutical and biotechnology industries. I graduated from UConn in Chemical Engineering. I was a senior manager at several medical device companies—including President/CEO of a laparoscopic imaging company. My Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certification. From 2009-2012, I was a lead auditor and instructor for BSI (one of the largest Notified Bodies). My specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications and 510(k) submissions. The most favorite part of my job is training others.
Bragging rights
6 awesome kids
Education
  • University of Connecticut
    1993
Basic Information
Gender
Male
Work
Occupation
Regulatory Consultant
Skills
Lead Auditor, Trainer, ISO Certification, CE Marking, Risk Management, CAPA, Health Canada, 510(k), FDA, Medical Devices.
Employment
  • Medical Device Academy
    Regulatory Consultant / Trainer
Places
Map of the places this user has livedMap of the places this user has livedMap of the places this user has lived
Currently
Vermont
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