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GreenData Site Launched/Company Offers Free BOM Scrub

October 9, 2008 6:05 am | Product Releases | Comments

GreenSoft Technology Inc., a leading provider of environmental compliance content management tools and services for the global electronics industry, has launched GreenData, a searchable database of environmental compliance and component information.

LISTED UNDER: Product Safety Compliance

Tray Handler Is Cleanroom Certified

September 10, 2008 8:33 am | Product Releases | Comments

The cleanroom certified DS1100 parts feeding machine is designed for medical and pharmaceutical applications. For cleanrooms, the system is manufactured almost entirely of stainless steel and has the ability to handle thin, thermoplastic trays.

LISTED UNDER: Cleanroom Services

Cleanroom Benches Optimize Airflow

September 10, 2008 8:33 am | Product Releases | Comments

Terra Universal has designed an advanced line of electropolished stainless steel work benches available for high-technology cleanrooms. These one-piece bullnose models enhance worker comfort while optimizing vertical laminar airflow without welds or cracks.

LISTED UNDER: Cleanroom Services
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The Combination Products Event for 2007

October 11, 2006 8:48 am | Product Releases | Comments

Reed Life Sciences is excited to announce PharmaMedDevice—the only comprehensive forum that fully illuminates the convergence of the medical device, pharmaceutical, and biologic industries. The inaugural event will be co-located with Interphex, April 24-26, 2007, at the Jacob K.

LISTED UNDER: Business Planning | Microbiology/Chemical Testing | Medical Device Testing

Cutting Through the Red Tape of Combination Product Approvals

October 11, 2006 8:47 am | Product Releases | Comments

As the development and use of combination products increases, the FDA realizes it needs to establish specific guidelines to oversee this technology. This article explores some of the pivotal issues pertaining to how a combination drug-device, drug-biologic, or device-biologic is regulated.

LISTED UNDER: Regulatory Affairs

Clarifying the Risk Management Requirements of IEC 60601-1, Third Edition

August 4, 2006 7:17 am | Product Releases | Comments

Guidelines that aid medical device manufacturers in the regulatory approval process are welcomed resources for engineers. The third edition of the IEC 60601-1 integrates risk management into the previously accepted safety standards for medical electrical equipment.

LISTED UNDER: FDA Compliance | Medical Device Testing

Designing a Cleaning Efficacy Program for Reusable Devices

August 3, 2006 12:17 pm | Namsa | Product Releases | Comments

There have been a number of changes in the last decade, which have raised questions as to how manufacturers should design cleaning and sterilization validation in order to be in compliance with new standards.

LISTED UNDER: Product Safety Compliance | Biocompatibility Testing | Microbiology/Chemical Testing

Are You Willing to Champion an Automation Project?

July 6, 2006 10:11 am | Product Releases | Comments

Before an automation project can be fully realized, it takes a champion to lead the charge and rally support in order to ensure success.

LISTED UNDER: Business Planning
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Emphasis on Systems Management: Optimizing Process and Business System Trends

April 4, 2006 12:16 pm | Product Releases | Comments

Medical device manufacturers are overburdened with managing a tremendous amount of data, in addition to maintaining the systems with which to utilize that information in order to keep pace with competition.

LISTED UNDER: Business Planning | Product Design | Product R&D

Emphasis on Corporate Culture: Embracing Quality System Compliance in Corporate Culture

February 7, 2006 5:39 am | Proven Process Medical Devices | Product Releases | Comments

Corporate culture plays an enormous role on the productivity of a company's workforce, yet it is an aspect that is seldom considered as a method with which to improve efficiency.

LISTED UNDER: FDA Compliance | Medical Device Testing | Product-Safety/Performance Testing

Emphasis on QA/QC Streamlining Quality Assurance and FDA Compliance

May 3, 2005 7:27 am | Product Releases | Comments

AT A GLANCE • CARs and CAPA defined • 21 CFR Part II initiatives • Part 820's GMP

LISTED UNDER: FDA Compliance | Product Design

What’s Ahead for Medical Device Companies

January 13, 2005 6:21 am | Product Releases | Comments

While prospects look promising, tough issues must be resolved to ensure that patients and caregivers have access to innovative technologies. Failure to address the anticompetitive practices of certain GPOs or to modify MDUFMA will result in long-term problems for the industry.

LISTED UNDER: Business Planning | Full Service Contract Manufacturing | Product R&D

Tackling Compliance Reviews

January 5, 2005 9:20 am | Product Releases | Comments

Pressed for time, tight on resources, and eager to reach their target market wherever in the world it is, medical device manufacturers are embracing third-party compliance reviews.

LISTED UNDER: FDA Compliance | Microbiology/Chemical Testing | Medical Device Testing

Training Institute

December 16, 2004 9:37 am | Product Releases | Comments

The ISA Training Institute and ISA Press have released their latest catalogs detailing more than 300 continuing education courses and 400 reference publications and standards.

LISTED UNDER: Business Planning

Looking at Intellectual Property From an Engineer’s Perspective

December 7, 2004 5:17 am | Product Releases | Comments

Medical device engineers work in a world characterized by innovation and invention, but it is also a land run by legal truths and consequences. This article provides an overview of patent and trademark law to help engineers traverse the legal terrain.

LISTED UNDER: Patents/Trademarks | Product Design

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