Featured Product
This Week in Quality Digest Live
FDA Compliance Features
Jill Roberts
Another way to know what’s too old to eat
Patricia Santos-Serrao
Four pharma quality trends
Del Williams
Preventing damage caused by large, suspended particles
Kari Miller
An effective strategy requires recruiting qualified personnel familiar with the process and technology

More Features

FDA Compliance News
Now is not the time to skip critical factory audits and supply chain assessments
Google Docs collaboration, more efficient management of quality deviations
Delivers time, cost, and efficiency savings while streamlining compliance activity
First trial module of learning tool focuses on ISO 9001 and is available now
Free education source for global medical device community
Good quality is adding an average of 11 percent to organizations’ revenue growth
Further enhances change management capabilities
Creates adaptive system for managing product development and post-market quality for devices with software elements
VQIP allows for expedited review and importation for approved applicants that demonstrate safe supply chains

More News

American National Standards Institute ANSI

FDA Compliance

Database Provides Centralized Info for Medical Device Professionals

Thousands of medical device standards in a single click.

Published: Monday, November 30, 2009 - 16:26

(ANSI: New York) -- The American National Standards Institute (ANSI) has joined forces with three of the biggest names in standards to develop an unprecedented resource for medical device standards and related information.

Medical professionals can now access more than 1,300 medical device standards from one single database developed jointly by ANSI, the Association for the Advancement of Medical Instrumentation (AAMI), ASTM International, and the German Institute for Standardization (DIN).

The new Medical Device Standards Portal provides a user-friendly single source for critical documents from AAMI, ASTM, DIN, the U.S. Food and Drug Administration (FDA), the International Electrotechnical Commission (IEC), and the International Organization for Standardization (ISO), as well as applicable European regulations.

All documents are available fully indexed and in a PDF format that is easily downloaded. By 2010, it is anticipated that documents will also be available in an HTML format, providing subscribers with more robust functionality.

The Medical Device Standards Portal arms medical device professionals with a powerful information management system that will enable users to:

  • Investigate. Access and link directly between more than 1,300 ASTM, ISO, IEC, AAMI, EN (DIN), FDA, and European regulations from one source
  • Monitor. Receive notifications when standards are updated and compare revisions with color-coded highlights denoting changes
  • Annotate. Integrate company practices and polices into the standards, preserving and passing on expertise
  • Collaborate. Add comments directly into the standards and share analysis with others

 

The database is powered by Citation Technologies Inc., a world leader in the field of online document management solutions. Earlier this year, ANSI and Citation announced an agreement to provide 17,765 standards developed by the International Organization for Standardization (ISO) on the Citation platform. The Institute also offers ANSI iPackages, which includes six collections from the ISO 14000 series of environmental management system (EMS) standards, through Citation.

To learn more about the Medical Device Standards Portal, visit www.medicaldevicestandards.com.

Discuss

About The Author

American National Standards Institute ANSI’s picture

American National Standards Institute ANSI

The American National Standards Institute (ANSI) coordinates the U.S. voluntary standardization and conformity assessment system, serving the diverse interests of more than 270,000 companies and organizations and 30 million professionals worldwide. ANSI is the official U.S. representative to the International Organization for Standardization (ISO) and, via the U.S. National Committee, the International Electrotechnical Commission (IEC).