Navigation Links
FDAnews Announces — Medical Device Risk Management: From Understanding to Applications, Nov. 5-6, 2014
Date:8/25/2014

Falls Church, VA (PRWEB) August 25, 2014

Medical Device Risk Management:
From Understanding to Applications
**Presented by Ombu Enterprises and FDAnews**

http:// http://www.fdanews.com/MDRiskMgmntChicago
All device professionals know they have to perform risk management.

And to do it, many firms rely on the widely accepted standard for product risk management: Failure Modes and Effects Analysis (FMEA).

But with the FDA and international regulatory bodies ramping up risk management requirements, and the potential for serious injury (even death) present in many medical devices, is FMEA enough? Experts say no.

FDA QSR guru Kim Trautman lays it out very clearly:
"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."

If that statement leaves devicemakerss grasping to find new methods to assure they’re performing the best possible risk assessment, there are options.

Here are five additional methods drawn from the chemical, aerospace, nuclear and food safety industries:

o     Event tree analysis (ETA)
o     Fault tree analysis (FTA)
o     Hazard analysis and critical control points (HACCP)
o     Preliminary hazard analysis (PHA)
o     Hazard and operability studies (HAZOP)

Where can devicemakers learn more about
'/>"/>

Source: PRWeb
Copyright©2014 Vocus, Inc.
All rights reserved

Page: 1 2 3 4

Related medicine news :

1. FDAnews Announces The FDA Unique Device Identification (UDI) Rule Virtual Conference
2. FDAnews Management Report: Managing Contract Manufacturers and Testing Labs
3. FDAnews Management Report: Implementing Risk-Based Verification and Validation
4. FDAnews Announces CDRH’s Office of Compliance Reorganization: A “One-On-One” with Office Director Steve Silverman, Webinar, Feb. 5, 2014
5. FDAnews Announces Device Software Verification and Validation: Get Ready for a New Breed of Investigators, On-Demand Webinar, Aug. 12, 2014
6. FDAnews Announces — Improving Your FDA Import Success Rate: Tips for Thinking Ahead of the FDAWebinar, Aug. 7, 2014
7. FDAnews Announces — Choosing the Right Drug Name: How to Increase Your Chances for Approval Webinar, July 22, 2014
8. FDAnews Announces — New Job Board Now Available on FDAnews.com
9. FDAnews Workshop: Conducting Advanced Root Cause Analysis CAPA Investigations, Sept. 17-18, 2014, Raleigh, NC
10. FDAnews New Workshop, 2 Weeks to Register — Innovative Process Validation Strategies for Medical Devices, Aug. 26-27, 2014, Bethesda, MD
11. FDAnews Announces Choosing the Best Device Sample Size for Verification and Validation: Tools to Safely Speed Your Device to Market, On-Demand Webinar, Aug. 27, 2014
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/27/2015)... “ Nursing Homes are starting to supplant hospitals ... of a recent April 2015 New York Times article. While ... the hospital, 20-plus years of research have documented the risks ... nursing homes are both safer for older patients and less ... homes varying widely, patients and family members may worry whether ...
(Date:5/27/2015)... May 27, 2015 In today's healthcare ... tighter, it can be challenging for doctors and hospitals ... edge treatments. , Austin-based HealthTronics, Inc. ... invasive, mobile medical therapies for clinically sophisticated applications. The ... the acquisition of Laser Ventures, Inc ., a ...
(Date:5/27/2015)... Black Book Rankings, well known ... the multiple services and software industries, conducted a ... ranked Electronic Health and Medical Record software systems ... focus on implemented EHR users, Black Book reveals ... the highest scores in client experience among small ...
(Date:5/27/2015)... (PRWEB) May 27, 2015 SAN ... in Gulfport Mississippi, is the first healthcare provider ... approach to chronic care management (CCM). In partnership ... Memorial is introducing RevUp, a new program that ... requirements and increase monthly reimbursements. This new, user-friendly ...
(Date:5/27/2015)... Cincinnati Veterans Affairs Women’s Health Clinic in partnership with ... proud to host the first annual Women Veterans awards ... the Freedom Center from 6 p.m. to 10 p.m. ... , This event honors and celebrates women tri-state Veterans for ... is free to the first 150 women Veterans who register ...
Breaking Medicine News(10 mins):Health News:BestNursingHomes.com Launches on National Senior Health and Fitness Day 2Health News:HealthTronics Invests in Additional Mobile Medical Technologies As Cost Efficient Solution for Hospitals, Doctors 2Health News:HealthTronics Invests in Additional Mobile Medical Technologies As Cost Efficient Solution for Hospitals, Doctors 3Health News:Cloud-Based Electronic Health Record firms sweep top physician satisfaction rankings for Small and Solo Practices, reveals 2015 Black Book survey 2Health News:Cloud-Based Electronic Health Record firms sweep top physician satisfaction rankings for Small and Solo Practices, reveals 2015 Black Book survey 3Health News:Cloud-Based Electronic Health Record firms sweep top physician satisfaction rankings for Small and Solo Practices, reveals 2015 Black Book survey 4Health News:Memorial Hospital Selects MD Revolution's Digital Health Platform to Deliver a New Form of Chronic Care Management 2Health News:Memorial Hospital Selects MD Revolution's Digital Health Platform to Deliver a New Form of Chronic Care Management 3Health News:Cincinnati VA Women’s Health Clinic Celebrates Women Veterans at Awards Banquet 2
... are frequently used as a replacement for missing teeth ... appearance. Previous research demonstrates that the placement of a ... of the implant, so practitioners often focus their treatment ... tissue surrounding the implant. A recent study published in ...
... Kim Announces the Jobseekers Facelift Giveaway ContestSAN FRANCISCO, May ... David W. Kim has established a Jobseekers Facelift ... number of jobs, older applicants (those over 40) see ... stay competitive with younger applicants. "Of course, one,s accomplishments ...
... Women who take folic acid supplements for at least one ... having a premature baby by half, according to research published ... , The study links pre-conceptional folate supplementation of at least ... to 70 percent, regardless of age, race or other factors. ...
... not prevent spread of waterborne, disease-causing germs.COLORADO SPRINGS, ... ?subject=Swim%20Diaper%20Study" target="_new"> scientific study demonstrates that ... the most common cause of documented recreational water ... Scientists from the University of North Carolina-Charlotte ...
... New treatments are minimally invasive without the side ... video from the Society of Interventional Radiology at: ... CANCER A minimally invasive interventional radiology treatment -- ... as effective as surgery but without the side ...
... the MidwestO,FALLON, Ill. May 12 MEDS, a ... today that it has named G. Scott Dillon ... more than 25 years of experience in clinical ... as chief operating officer of NES Holding Inc. ...
Cached Medicine News:Health News:Placement of dental implants results in minimal bone loss 2Health News:Want to Help Your Job Hunt? Win a Facelift! 2Health News:Taking folic acid for a year before pregnancy may reduce risk of preterm birth 2Health News:New Study: Keep Kids With Diarrhea Out of Pool - Swim Diapers Not Best Solution 2Health News:New Study: Keep Kids With Diarrhea Out of Pool - Swim Diapers Not Best Solution 3Health News:VIDEO from Medialink and the Society of Interventional Radiology: Prostate and Kidney Cancer - New Life-Changing Developments 2Health News:G. Scott Dillon Named President and CEO of MEDS 2
(Date:5/27/2015)... , May 27, 2015 Doctors from ... at Children,s National Health System are ... to treat osteoid osteoma, a benign but painful ... adults, using an experimental magnetic resonance-guided high-intensity focused ultrasound ... and 10-year-old Niyati Shah , have been treated ...
(Date:5/27/2015)... -- Research and Markets ( http://www.researchandmarkets.com/research/9ffv95/2015_strategies ... "2015 Strategies in the European Coagulation Testing Market" ... comprehensive five-country report contains 500 pages, 120 tables, ... potential market entrants identify and evaluate business opportunities ... the next five years. The report ...
(Date:5/27/2015)... Research and Markets( http://www.researchandmarkets.com/research/d85hx9/global_rapid ) has announced the addition ... - Applications and Technologies" report to their offering. ... estimated at US$19.4 billion in 2014, forecast at US$20.4 ... CAGR of 5.7% between 2014 and 2020 to reach ... global market for Rapid Medical Diagnostic Kits (MDKs) has ...
Breaking Medicine Technology:Children's National first in US to destroy bone tumors with incisionless surgery 2Children's National first in US to destroy bone tumors with incisionless surgery 3Children's National first in US to destroy bone tumors with incisionless surgery 4European Coagulation Testing Market Strategies 2015 2Global Rapid Medical Diagnostic Kits Market - 2015-2020 Applications and Technologies Analysis of the $27 Billion Industry 2Global Rapid Medical Diagnostic Kits Market - 2015-2020 Applications and Technologies Analysis of the $27 Billion Industry 3Global Rapid Medical Diagnostic Kits Market - 2015-2020 Applications and Technologies Analysis of the $27 Billion Industry 4
... Diagnostics Incorporated (NYSE: DGX ), the world,s ... today it has commenced a tender offer through its ... the outstanding shares of common stock (the "Shares") of ... the world,s pioneers in genetic diagnostics discovery and development ...
... 2011 Bionovo, Inc. (Nasdaq: BNVI ), a ... and effective treatments for women,s health and cancer, today announced ... testing the safety of two doses of Menerba in postmenopausal ... MF101-008), also known as "menopausal hot flashes." ...
Cached Medicine Technology:Quest Diagnostics Commences Tender Offer for Acquisition of Celera 2Quest Diagnostics Commences Tender Offer for Acquisition of Celera 3Bionovo Announces Enrollment Started in the Menerba (MF101) Phase 1 "Tolerability" Clinical Trial for Menopausal Hot Flushes 2Bionovo Announces Enrollment Started in the Menerba (MF101) Phase 1 "Tolerability" Clinical Trial for Menopausal Hot Flushes 3
Sebia's Hb AFSC Control provides excellent resolution of normal hemoglobins A & F and abnormal hemoglobins S & C. The control is designed for use with Sebia's Hydragel Hemoglobin and Hydragel Acid He...
The HYRYS™ 2 densitometer is reflective of Sebia's expertise in the development and design of imaging systems and densitometers utilized in the electrophoresis field....
Eliminating the need for any manual pipetting, the HydraPLUS delivers precise micro-volumes of sample directly from primary tubes to four HYDRASYS sample applicators contained in a built-in humidity ...
Inquire...
Medicine Products: