Regulatory Articles
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Managing Risk In Medical Connectors
7/29/2014
This paper will help to educate designers and manufacturers of medical devices who integrate electrical connectors into their design on some recent changes made by the FDA, and the implications of the new regulations.
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A Comparison Of Process Validation Standards
6/6/2014
U.S. life science firms are currently subject to two different process validation standards: the Global Harmonization Task Force’s Process Validation Guidance and FDA’s Process Validation: General Principles and Practices. These standards have considerable overlap, both officially and practically, across the drug and medical device industries. Previously, all FDA divisions followed a single guidance document, but that document has long since been superseded by new regulations and advances in validation science. This article examines the differences and similarities between the two guidance documents and concludes that any firm manufacturing product whose predicate regulations require process validation (drugs, devices, Active Pharmaceutical Ingredients, biologics, or human-based tissues) should incorporate the philosophies and directives of both to meet Agency expectations and to assure the highest quality of their products. By Jeff Boatman, senior subject matter expert, medical devices and quality systems, QPharma Inc.
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Don’t Use Last Century’s QMS Tools For This Century’s Medical Devices
5/14/2014
It goes without saying that a well organized and auditable quality management system (QMS) is job number-one for medical device manufacturers. However, a surprising number of organizations are still using Microsoft Office — specifically Word and Excel, both of which were invented in the 1980s — to manage their quality and design systems. By Steve Chalgren, Arena Solutions
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A 15-Minute Guide To Clinical Trial Document Management And The eTMF
5/30/2013
At the Drug Industry Association’s (DIA) annual meeting held in June 2012, the TMF Reference Model Working Group released TMF reference model 2.0, which included significant updates from the group’s 2010, 1.0 release.
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Medical Device Companies Turning To New Breed Of Supply Chain Partner
4/19/2013
Medical Device companies are well aware of the strategic and operational impact of tougher reimbursement policies and the soon to be implemented medical device tax.
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Improving Quality Processes For Medical Device Development And Manufacturing
3/21/2013
Organizations that consistently develop and launch new products efficiently in an environment of increasing regulatory scrutiny, successfully manage regulatory risk. By Mike Kuehne, ACSYS, Inc.
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Health Care Supply Chain Requires Regulatory Expertise And Execution
2/26/2013
In the U.S. health care supply chain, before a medical device or drug can be shipped -- state and county licenses must be secured, FDA Quality Systems regulations must be complied with, and accreditations must be earned. The health care supply chain plays a key role in patient safety by ensuring the integrity of products from the time they are manufactured to the time they are delivered to a health care provider or patient.
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Medical Device Quality Systems Demystified: Why Companies Need Best-Of-Breed ERP, PLM And EQMS
4/19/2011
Intense global pressures, such as more stringent regulatory scrutiny, tax increases and reimbursement challenges are causing stalled top-line growth for medical device organizations and prompting them to find ways to increase operational efficiencies. By Sparta Systems, Inc.
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White Paper: Medical Device Quality Systems Demystified: Why Companies Need Best-Of-Breed ERP, PLM And EQMS
4/19/2011
Intense global pressures, such as more stringent regulatory scrutiny, tax increases, and reimbursement challenges are causing stalled top-line growth for medical device organizations and prompting them to find ways to increase operational efficiencies. By Sparta Systems, Inc.
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ERP, Document Management & Other Enterprise Applications: Can They Fulfill The Quality Mission Alone?
12/3/2010
Quality and IT executives alike face increasing pressure to implement solutions that allow the highest level of holistic control and oversight on the quality of their operations. By Sparta Systems, Inc.