Inside FDA Compliance

International Organization for Standardization’s picture

By: International Organization for Standardization

(ISO: Geneva) -- To ensure that medical devices do not irritate the skin or eyes, or cause other adverse reactions, the International Organization for Standardization (ISO) has published a testing standard for checking their safety prior to marketing and use.

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By: ASME

(ASME: New York) -- The American Society of Mechanical Engineers (ASME) has announced the 5th Frontiers in Biomedical Devices Conference and Exhibition, examining the technology that is driving innovation in the biomedical industry. The conference is set for Sept. 20–21, at the Island Hotel in Newport Beach, California.

Sparta Systems Inc.’s picture

By: Sparta Systems Inc.

(Sparta Systems: Holmdel, NJ) -- TrackWise SelectStart is a purpose-built quality management solution created specifically for small to medium-size companies across different segments of life science industries. These emerging companies have the same rigorous quality and regulatory requirements as multibillion dollar organizations but don’t have the same resources and budget. They face pressure to maintain the highest level of quality in every facet of their operations and must maintain compliance with a growing list of regulations, including:

Veriteq Instruments Inc.’s picture

By: Veriteq Instruments Inc.

(Veriteq: Richmond, BC Canada) -- Quality engineers working in the pharmaceutical and similarly regulated industries seeking continuous monitoring systems specifically geared for larger enterprises can deploy viewLinc 3.5, recently launched by Veriteq, a Vaisala company.

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By: Pilgrim Software

(Pilgrim Software: Tampa, FL) -- Pilgrim Software Inc., a provider of enterprise risk, compliance, and quality management (ECQM) software solutions, has announced the global availability of its expanded Regulatory Reporting platform. Rounding out the platform, the new MedDRA adapter integrates with Pilgrim’s Complaints Management solution to ease adverse-event reporting to global regulatory bodies.

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By: Locus Technologies

(Locus Technologies: San Francisco) -- Locus Technologies (Locus), a provider of web-based environmental compliance and information management software, has introduced an accreditation process for analytical laboratories to deliver analytical data into Locus’ award-winning, cloud-based environmental information management (EIM) system. A growing need exists for a standardized format for transmitting environmental electronic data. There are more than 15 different standards in use in the United States alone, most of which are antiquated.

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By: Pilgrim Software

(Pilgrim Software: Tampa, FL) -- New food safety regulations moving through the U.S. Congress, combined with the Global Food Safety Initiative (GFSI), demand greater safety management by food processors. At the 2010 Institute of Food Technologists Annual Meeting, Symposium 171, “The Operational Implications of New Food Safety Regulations and GFSI” will explore the issue. Pilgrim Software’s director of industry solutions, Deborah Kacera, will present at the Symposium, Monday, July 19, at 1:30 p.m., at Chicago’s McCormick Place.

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By: International Quality and Productivity Center IQPC

(IQPC: New York) -- The International Quality and Productivity Center (IQPC) will hold its 10th Lean Six Sigma for Biotech, Pharma, and Medical Device Excellence event in San Diego, July 26–28, at the Hilton San Diego Resort.

Explore how to leverage lean Six Sigma and operational excellence by:

• Encouraging less talk, more action—engaging leaders to transition more quickly from agreement to commitment

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