Navigation Links
FDAnews Announces Medical Device Risk Management Conference, July 11-12, 2013, Boston, MA
Date:4/26/2013

FALLS CHURCH, Va., April 26, 2013 /PRNewswire-iReach/ -- Medical Device Risk Management
Beyond FMEA —New Tools to Assure Your Risk Management Program Meets New Standards
**Presented by Ombu Enterprises and FDAnews**
July 11-12, 2013 — Boston, MA

www.fdanews.com/MDRiskMgmnt

(Photo: http://photos.prnewswire.com/prnh/20130426/CG02614)

Is Failure Modes and Effects Analysis (FMEA) the cornerstone of your risk management program?  Consider this quote from the FDA's QSR expert Kim Trautman :

"Are FMEA or FMECA… good tools? Yes. They are very good tools that can be utilized. Are they in and of themselves a risk management system? Absolutely not.  I can't tell you how many manufacturers I have seen that have tried to present their risk management system by simply presenting a FMEA — that is not a risk management system. Do not make the mistake of presenting FMEAs as your whole risk management system."

Imagine, in two days you can learn about 5 new risk management tools and 4 emerging new standards to transform your risk management program. 

FDAnews and Dan O'Leary, President of Ombu Enterprises, have developed a comprehensive workshop that is packed with immediate use tools and techniques to improve your current program.  This course goes well beyond FMEA to show you how its limitations could be your downfall.

Plus, the program provides interactive sessions to put the tools to use in mock scenarios.

You'll learn how ETA, FTA, HACCP, PHA and HAZOP could be the keys to avoiding your next device disaster.

And as a bonus; this tightly focused workshop, will explain 4 new standards that call out ISO 14971 and how they can be integrated into your program.  The new standards include:

  • IEC 60601-1, Medical electrical equipment — Part 1: General requirements for basic safety and essential performance
  • IEC 62304, Medical device software — Software life-cycle processes
  • FDA Draft Guidance — Applying Human Factors and Usability Engineering to Optimize Medical Device Design
  • The basic concepts of the assurance case

Seating is at a premium for this event — Register today.  Other areas the event will focus on include:

  • How the FDA and international regulatory bodies measure the severity of a risk and what the different levels of seriousness are
     
  • How to create and administer a risk management file — think of it as your risk management file cabinet
  • Understand how to score risks and create a risk "scorecard" — how to use severity and probability
     
  • Tips to assure that all your risk management reports contain the 9 checklist items all reports should have
     
  • And much more

You'll leave this workshop a much better risk management professional.

Register today

Who Will Benefit

  • Project managers involved in design and development
  • Design engineers
  • Quality engineers
  • Manufacturing engineers
  • Quality auditors
  • Production managers
  • Scientists involved in device research and development
  • Medical staff evaluating risk, safety or effectiveness
  • Quality or regulatory staff assigned to complaint, CAPA or MDR management
  • Training personnel
  • General/corporate counsel

Meet Your Instructor

Dan O'Leary has more than 30 years of experience in quality, operations and program management in regulated industries including aviation, defense, medical devices and clinical labs.  He is president of Ombu Enterprises LLC, a consultancy focused on operational excellence and regulatory compliance serving small manufacturing companies. O'Leary has a master's degree in mathematics; is an ASQ certified biomedical auditor, quality auditor, quality engineer, reliability engineer, and six sigma black belt; and is certified by APICS in resource management.

CONFERENCE DETAILS

Medical Device Risk Management
Beyond FMEA —New Tools to Assure Your Risk Management Program Meets New Standards
**Presented by Ombu Enterprises and FDAnews**
July 11-12, 2013 — Boston, MA

TUITION: $1,797 per attendee

4 Easy Ways to Register

Online:     www.fdanews.com/MDRiskMgmnt
By phone: 888-838-5578 or 703-538-7600
Fax:        703-538-7676
Mail to:     FDAnews
                        300 N Washington St
                        Ste 200
                        Falls Church, VA, USA  22046-3431



Media Contact:

Jeff Grizzel FDAnews, 703-538-7668, jgrizzel@fdanews.com



News distributed by PR Newswire iReach: https://ireach.prnewswire.com


'/>"/>
SOURCE FDAnews
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. FDAnews announces Fourth Annual Supplier Quality Congress
2. FDAnews Announces Medical Device Mobile Apps Virtual Conference
3. FDAnews announces Third Annual Pharmaceutical Labeling Summit
4. FDAnews announces Fifth Annual Risk Management & Drug Safety Summit
5. FDAnews announces Biopharmaceutical Good Distribution Practices Summit
6. FDAnews Announces Clinical Quality Assurance Workshop
7. Precision Optics Corporation Announces $1 Million Order for Microprecision™ Based Endoscopes
8. Young Innovations, Inc. Announces Record Sales and EPS for the Quarter Ended March 31, 2012
9. JDRF Announces Research Collaboration with Dexcom, Inc. to Develop "Smart Transmitter" Technology to Accelerate Artificial Pancreas Studies
10. Misonix Announces New Distribution Agreement For Panama
11. University of Maryland BioPark Announces MedImmunes Dr. Bahija Jallal as Newest Member of Board of Directors for UM Health Sciences Research Park
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/12/2016)... N.J. , Feb. 12, 2016  Innophos Holdings, Inc. ... and nutritional specialty ingredients, today announced that it will host ... 10:00 am ET to discuss its fourth quarter and full ... --> The press release detailing fourth quarter and full ... after market close. --> ...
(Date:2/12/2016)... 2016 (Kanadische ... http://www.sedar.com ) und der Website ... --> http://www.sedar.com ) und ... abrufbar.    --> Telesta ... Konzernabschluss des zweiten Quartals und die ...
(Date:2/12/2016)... JOSE, Calif. , Feb. 12, 2016  SI-BONE, Inc., a ... System ® ("iFuse"), a minimally invasive surgical (MIS) device indicated ... that National Government Services, Inc. (NGS), the Medicare Administrative Contractor (MAC) ... Illinois , Maine , Massachusetts ... , New York , Rhode ...
Breaking Medicine Technology:
(Date:2/12/2016)... ... February 12, 2016 , ... The law firm of Morrow, Morrow, ... The purpose of these scholarships is to encourage applicants to pursue a degree ... employment within these two parishes. , “We have available jobs in St. Landry ...
(Date:2/12/2016)... VA (PRWEB) , ... February 12, 2016 , ... CDRH Enforcement Trends: , Back to ... , As Winston Churchill said, “Those who don’t learn from history ... show what to expect when they come knocking this year. But that takes time. ...
(Date:2/12/2016)... Angeles, CA (PRWEB) , ... February 12, 2016 , ... ... With a hectic schedule, a demanding job, and no time to decompress, Rabinowitz found ... she dedicated herself to meditation for its impact on her life, implementing a 20-minute-per-day ...
(Date:2/12/2016)... Appleton, Wis. (PRWEB) , ... February 12, 2016 ... ... its second Lean Leadership Series at Zuckerberg San Francisco General Hospital on April ... to practice new behaviors and create new habits. The workshops cover a broad ...
(Date:2/12/2016)... ... February 12, 2016 , ... Fisher House Foundation Chairman ... John J. Lee, Nevada Military Support Alliance president Scott Bensing, and Peggy Kearns Director, ... VA Southern Nevada Healthcare System. This will be the first Fisher House in ...
Breaking Medicine News(10 mins):