Preparing for New European Technical File and Design Dossier Requirements

%name Preparing for New European Technical File and Design Dossier RequirementsPreparing for new European technical file and design dossier requirements webinar is presented by Rob Packard, President of Medical Device Academy, will help you prepare for your design dossier submissions if you design and develop spinal implants and other high-risk devices. 

In 2007, the risk classification for hip, knee and shoulder implants was changed from Class IIb to Class III. Now the Europeans are proposing new, tougher medical device regulations. This includes the reclassification of spinal implants from Class IIb to Class III.

This webinar will cover:

  • Differences between a technical file and design dossier
  • How to write a STED Summary for Each Section
  • Selection of “Special Notified Bodies” (SNBs)
  • How to create a TF/DD Index that Doubles as a DMR for the FDA
  • Recent Trends in Notified Body Nonconformities for Technical Audits
  • Which parts of your existing technical file and design dossier need to be stronger
  • WHAT YOU GET…
  • Access to the Live GoToWebinar & Recording
  • PowerPoint Training Presentation Slide Deck
  • Template for technical file and dossier dossier Index (referencing new proposed regulations & GHTF)
  • GHTF SG1/N011:2008 Guidance Document
  • Essential Requirements Checklist for new proposed regulations
  • GAP Analysis of Risk Classification
%name Preparing for New European Technical File and Design Dossier Requirements
Preparing for New European Technical File / Design Dossier Requirements

Preparing for 2014 European CE Marking Requirements webinar presented by Rob Packard, QA/RA Expert, Medical Device Academy, will help you prepare for your design dossier submissions if you design and develop spinal implants.

Price: $129.00

exam6 150x150 Preparing for New European Technical File and Design Dossier Requirements
EXAM – Preparing for New Technical File and Design Dossier Requirements

This is a 10 question quiz with multiple choice and fill in the blank questions. The completed quiz is to be submitted by email to Rob Packard as an MS Word document. Rob will provide a corrected exam with explanations for incorrect answers and a training effectiveness certificate for grades of 70% or higher.

Price: $49.00

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About Your Instructor

Medical Device Academy Robert Packard Preparing for New European Technical File and Design Dossier RequirementsRobert Packard is a regulatory consultant with 20 years experience in the medical device, pharmaceutical and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Robert was a senior manager at several medical device companies—including President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certification. From 2009-2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Robert’s 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 his job is training others. Specialties: CE Marking, Canadian Medical Device Applications, Post-Marketing Activities, Supplier Quality, CAPA, Risk Management, Auditing, Sterilization Validation, Lean Manufacturing, Silicone Chemistry, Extrusion, Bioprocess Engineering, and Strategy. He can be reached via phone 802.258.1881 or email. You can also follow him on Google+, LinkedIn or Twitter.

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