Regulatory Affairs
Think Before Sending that Email
April 18, 2013 2:39 pm | by Patricia J. McGrath and Christopher M. Scharff, Shareholders, McAndrews, Held & Malloy | Blogs | CommentsThe medical device industry is, without question, one of the most litigious industries. Medical device companies are constantly engaging in high-stakes patent or trade disputes, defending against product liability claimants, or fending off new market entrants. So when a seemingly harmless communication becomes a major piece of evidence in a case brought against your company, you do not want to be the one who hit “Send.”
LISTED UNDER: Business Planning | Patents/Trademarks | Regulatory AffairsThogus Launches Jalex, a Medical Device Company
October 15, 2012 4:15 pm | by Thogus | News | CommentsThogus, a 62-year old custom injection molder expands services to include rapidly developing medical device market. JALEX Medical, LLC will focus exclusively on biomedical engineering, product development and regulatory/quality assistance. JALEX joins Thogus and Rapid Prototyping and Manufacturing (rp+m) under the same roof, fostering accelerated product design through complete production.
LISTED UNDER: Regulatory Affairs | Full Service Contract Manufacturing | Design ServicesIs Your Supply Base Changing Without You?
February 7, 2007 10:03 am | Articles | CommentsWhile RoHS doesn’t directly affect medical device manufacturers in the U.S., many component suppliers are changing their products to be in compliance with the regulation.
LISTED UNDER: Regulatory Affairs | Microbiology/Chemical Testing | Full Service Contract ManufacturingCutting Through the Red Tape of Combination Product Approvals
October 11, 2006 8:47 am | Kirkpatrick & Lockhart Nicholson Graham Llp | Product Releases | CommentsAs 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 AffairsNew Set of SOPs
November 3, 2004 9:24 am | Product Releases | CommentsThe Thomson Center for Clinical Research Practice, Wellesley, MA, has published "Standard Operating Procedures for Good Clinical Practice by Sponsors of Medical Device Research." These SOPs address the unique regulatory and business environment of medical device clinical trials.
LISTED UNDER: Regulatory AffairsDeveloping a Strategy for Global Development Teams
November 2, 2004 4:38 am | Product Releases | CommentsA versatile regulatory compliance strategy is crucial to tapping into the expertise of global product development teams. This article outlines four steps to achieving a successful solution.
LISTED UNDER: Regulatory Affairs
