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Robert Packard
Worked at Medical Device Academy
Attended University of Connecticut
Lives in Vermont
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#MedicalDeviceAcademy  published a new case study on CE Marking approval of medical devices in Europe.
Case study explains the process for CE Marking approval of a medical device.
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#MedicalDeviceAcademy  published an article reviewing the requirements for re-validation of ethylene oxide sterilization in accordance with ISO 11135-1.
This article reviews some of the factors to consider when you are evaluating the need to repeat your ethylene oxide sterilization validation.
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#MedicalDeviceAcademy published an article explaining how to establish and validate bioburden limits for component parts and finished medical devices.
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#MedicalDeviceAcademy  published an article providing an update on the Medical Device Single Audit Program (MDSAP) Pilot.
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#MedicalDeviceAcademy  published a new case study related to 510k submissions.
Case study explaining 510k submission process in order to obtain clearance from the US FDA for marketing a new medical device.
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#MedicalDeviceAcademy  posted an article summarizing two recent updates related to electrical safety standards.
This article summarizes updates on electrical safety standards for medical devices-IEC 60601.
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In his circles
504 people
 
#MedicalDeviceAcademy  published a case study related to section 4 of a 510k submission--the indications for use. The case study involves a pediatric pedicle screw product.
The example of a spinal pedicle screw 510k submission was used for this indications for use case study.
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#MedicalDeviceAcademy  published a new article explaining how to prepare Section 14 of a 510k submission on the topic of sterilization validation.
This article explains the process for preparing the sterilization validation and shelf-life section of a 510k submission.
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Robert Packard

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Learn details about the potential impact of the new European Medical Device Regulation (EMDR) for medical device manufacturers and suppliers of outsource manufacturing. By Rob Packard During the last two decades, there has been a steady increase in the outsourcing of medical device manufacturing to contract manufacturers, service providers, and component suppliers.
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#MedicalDeviceAcademy  published a new case study article about performance testing for 510k submissions.
Performance Testing for a 510k Submission-Case Study-Part 2 explains the performance testing for a 510k submission in order to obtain fda clearance.
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#MedicalDeviceAcademy  - new supplier tool kit available for download. Inludes 5 templates to help auditors prepare for supplier audits.
This tool kit consists five document templates for supplier auditing.
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#MedicalDeviceAcademy  released a new webinar for training medical device companies on good documentation practices. There is also a training exam available.
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People
In his circles
504 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
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New version BS EN ISO 14971:2012 released - July 2012
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Guest Editorial: Rebuttal to FDA’s Internal Report on EU Medical Device ...
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