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Q: Medical Device Articles ( Answered,   1 Comment )
Question  
Subject: Medical Device Articles
Category: Health
Asked by: debsmith-ga
List Price: $10.00
Posted: 01 Jul 2005 09:13 PDT
Expires: 31 Jul 2005 09:13 PDT
Question ID: 539112
I?m looking for some good websites (hopefully you can find at least 5)
that feature general articles exclusively for medical devices.  I?ve
come across one - Device Link - which I use frequently.  I also use
the FDA?s website?.but I?m looking for additional ones.

Some of the topics I like covered are:  Sterilization, Medical Device
Submission, ISO 14971 (risk management), ISO 13485, Warning Letters
(dealing specifically with medical devices), 510(k) submissions and
medical device advertising?..etc?.basically something similar to
Device Link.
Answer  
Subject: Re: Medical Device Articles
Answered By: bobbie7-ga on 01 Jul 2005 10:25 PDT
 
Hello Debsmith , 

Below you will find a number of informative sites related to the
medical device industry.


The Medical Device Manufacturers Association (MDMA)

?The Medical Device Manufacturers Association (MDMA) is a national
trade association based in Washington, D.C. that represents
independent manufacturers of medical devices, diagnostic products and
healthcare information systems.?

 ?MDMA's mission is to promote public health and improve patient care
through the advocacy of innovative, research-driven medical device
technology.?

 ?MDMA plays a proactive role in helping to shape policy that impacts
the medical device innovator.  To achieve these goals, MDMA represents
its members' collective interests before the United States Congress,
the Food and Drug Administration (FDA), the Centers for Medicare and
Medicaid Services (CMS), and other federal agencies that develop or
implement policies that affect the medical device industry.  MDMA
encourages its members to actively engage in the advocacy process
through MDMA Task Force participation and grassroots mobilization.?
http://www.medicaldevices.org/public/

Medical Device Industry Resources
http://www.medicaldevices.org/public/links/default.asp#MeddevResources


============================================


Medical Design Online

?Are you searching for a better understanding of the medical device
approval process? Want to learn more about developing cardiovascular
devices to prevent restentosis? Interested in finding instrumentation
applications? Need to identify and select suppliers? Then you need the
expert advice of Medical Design Online, the premier sourcing site for
the medical device industry.?
http://www.medicaldesignonline.com/content/homepage/default.asp


============================================


Advanced Medical Technology Association (AdvaMed)

?AdvaMed is the world's largest medical technology association
representing manufacturers of medical devices, diagnostic products and
medical information systems. AdvaMed?s more than 1,300 members and
subsidiaries manufacture nearly 90 percent of the $80 billion of
health care technology purchased annually in the United States and
more than 50 percent of the $175 billion purchased annually around the
world. AdvaMed members range from the largest to the smallest medical
technology innovators and companies. Nearly 70 percent of our members
have fewer than $30 million in sales annually.?
http://www.advamed.org/aboutadvamed.shtml


============================================


Medical Design Technology

Medical Design Technology keeps the medical device manufacturing
industry up to date with the latest developments in this growing and
increasingly competitive field.
http://www.mdtmag.com/scripts/default.asp
 

============================================


The Global Harmonization Task Force

The Global Harmonization Task Force (GHTF) was conceived in 1992 in an
effort to respond to the growing need for international harmonization
in the regulation of medical devices.

The five founding members of the GHTF are: EuropeanUnion, United Status,  
Canada, Australia and Japan. 

http://www.ghtf.org/


============================================


ECRI's Medical Device Safety Alerts

?ECRI's Medical Device Safety Alerts (MDSR) database. MDSR is a 
repository of medical device incident and hazard information
independently investigated by ECRI, a nonprofit health services
research agency. MDSR is not an alerting service, but a periodically
updated review of the types of problems that have occurred with
medical devices and lessons learned over the past three decades. It
focuses on the steps that medical device users can take to prevent or
reduce medical device risks to patient care and healthcare worker
safety.?
http://www.mdsr.ecri.org/


============================================

RegSource.com 

?Site aims to accelerate the development of biotechnology and medical
devices by radically improving access to global regulatory and other
product development information. The site provides regulatory affairs
information from agencies such as the US Food and Drug Administration,
European Medicines Evaluation Agency (EMEA), Canada's Health
Protection Branch (HPB), Medicines Control Agency (MCA) and other
international regulatory bodies. You can even download governmental
forms here.?
http://www.regsource.com/Comments/About_Us/about_us.html


===================================
Other sites that might interest you
===================================

Medical Device Resource Center 
A wealth of links and information to medical device related websites
http://geocities.com/medicalequip_go/


Life Science Branch of Industry Canada
Canada?s Medical Device Sector
http://strategis.ic.gc.ca/epic/internet/inlsg-pdsv.nsf/en/h_hn00002e.html


Association of Medical Diagnostics Manufacturers
http://www.amdm.org/


Medical Manufacturing Resources MAgazine
http://www.jmdpublications.com/magazine.cfm


Search terms used: 
Medical device resources OR associations OR links OR directory


I hope this is helpful.

Best regards,
Bobbie7
Comments  
Subject: Re: Medical Device Articles
From: healthcanada-ga on 08 Jul 2005 06:18 PDT
 
These are good Deb, but you may want to consider the following:

Don?t forget the EU?s website, particularly if you intend to sell overseas:

http://europa.eu.int/comm/enterprise/medical_devices/index_en.htm

This website is developed and managed by European Commission,
Directorate General for Enterprise and Industry, and aims to
disseminate information on all EU policies, actions and initiatives
promoting growth and development, with a view to strengthening the
competitiveness of EU enterprises.
More than 22,000 documents are now available to users. The site offers
an up-to-date coverage of EU enterprise policies, specific pages
covering 25 industry sectors as well as news, speeches, electronic
publications and essential information on events, EU business
statistics and benchmarking. This website also hosts open
consultations and forums.

Another one that seems to be popular these days is:

Medical Device School
www.medicaldeviceschool.com
This site is particularly useful in that there is a lot of information
on overall aspects of the Medical Device industry from FDA to other
regions of the world.


And as you indicated my favorite tends to be Device Link, or at least
it used to be.  They still have a lot of information.  I find though
that recently their articles tend to be less generic and useful.

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