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Robert Packard
Worked at Medical Device Academy
Attended University of Connecticut
Lives in Vermont
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#MedicalDeviceAcademy released a blog providing a status update on unannounced audits by Notified Bodies.
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#MedicalDeviceAcademy  provided a step-by-step guide to registration and listing devices with the US FDA (CDRH). The blog includes links to guidance documents and other FDA resources.
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Hey Rob! Just finished my design controls with Jon Speer and Greenlight.guru! His software works great! Moving right along! Thanks for your ongoing blogging help and for connecting me with Jon.
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#MedicalDeviceAcademy blog reviews 5 of the most common reasons for why fda warning letters are issued by CDRH, and preventive actions are suggested for each of the five reasons.
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#MedicalDeviceAcademy reviews five common miskes related to conducting FDA recalls.
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#medicaldeviceacademy  identifies 5 criteria for a certified internal auditor program of medical device lead auditors for quality systems auditing and supplier auditing. 
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Interesting!! Thanks again Rob!
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#MedicalDeviceAcademy author, +Jonathan Bretz, published a blog explaining what the FDA's GUDID is. 
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#MedicalDeviceAcademy published a new blog by Jon Bretz that provides a roadmap with 8 steps to UDI planning.
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#MedicalDeviceAcademy  identifies how to use medical device remote audits effectively, save time and resources, and when you should not conduct audits remotely.
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#MedicalDeviceAcademy shares an interview and advice from a former FDA investigator on best practices for responding to FDA 483s.
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#MedicalDeviceAcademy guest Author, Jon Bretz, summarizes the cost factors for UDI planning and implementation.
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Thanks again Rob
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#MedicalDeviceAcademy reviews two new guidance documents released by the FDA for submission of 510(k) for electrosurgical devices.
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Nice article Rob...Still working on Emily...
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#MedicalDeviceAcademy explains how to use a 7-step approach to process auditing for the complaint handling process.
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People
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
Story
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 and a beautiful wife that keeps us all healthy, happy and safe.
Education
  • University of Connecticut
    1993
Basic Information
Gender
Male
Robert Packard's +1's are the things they like, agree with, or want to recommend.
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New version BS EN ISO 14971:2012 released - July 2012
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New version BS EN ISO 14971:2012 released - July 2012 ISO 14971 - Medical Device Risk Management

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Do You Measure RoR? You Should.
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Guest Editorial: Rebuttal to FDA’s Internal Report on EU Medical Device ...
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