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  The Silver Sheet
  [4 followers]  Follow
   Full-text available via subscription Subscription journal
   ISSN (Print) 1068-5324
   Published by Informa plc Homepage  [14 journals]
  • PODCAST: 10 Tips For Writing Effective IFUs For Medical Devices –
           And More
    • Abstract: Online-Only Content >>> In the wake of troubling patient infections and deaths due to improperly sterilized duodenoscopes, human factors experts Michael Wiklund and Jonathan Kendler of UL-Wiklund Research & Design provide tips on writing effective instructions for use in this "Silver Sheet" podcast.
      PubDate: Mon, 30 Mar 2015 11:30:00 -040
  • PODCAST: UDI 2.0 – What You Can Learn From Other Manufacturers'
           Unique Device Identification Mistakes
    • Abstract: Online-Only Content >>> In his second "Silver Sheet" podcast appearance, Jay Crowley – FDA's former senior advisor for patient safety and the Founding Father of the UDI system – addresses roadblocks companies have faced and how they can learn from others' mistakes. Crowley is currently VP of UDI Services and Solutions with consulting firm USDM Life Services.
      PubDate: Mon, 23 Mar 2015 11:30:00 -040
  • Apply Risk Analysis Concepts To Quality Data Reviews To Pinpoint Severe
           Device Problems Faster
    • Abstract: Online-Only Content >>> Device-maker Steris' director of regulatory affairs explains why it's important for device manufacturers to view quality data through the prism of risk management.
      PubDate: Thu, 19 Mar 2015 12:45:01 -040
  • Let's Talk About Risk: FDA Plans Meeting On Postmarket Risk Management
    • Abstract: Online-Only Content >>> FDA will hold an interactive workshop on April 21 to discuss the "clinical considerations of risk in the postmarket environment." The meeting will build on a process launched last fall when representatives from industry and FDA met to establish draft principles for managing unanticipated risks for marketed devices.
      PubDate: Thu, 19 Mar 2015 02:15:01 -040
  • Industry, FDA Coming Together On Risk Management For Marketed Devices
    • Abstract: Online-Only Content >>> Representatives from the device industry and FDA are trying to establish common ground for how to assess and manage risk of potential safety or compliance issues that crop up for marketed devices.
      PubDate: Mon, 16 Mar 2015 21:30:00 -040
  • Message From The Editor: A Move To Strengthen Our Offering
    • Abstract: "The Silver Sheet" has been digging deep into the intricate world of medical device quality control for almost 20 years. Right from the inception of the Quality System Regulation in 1996, we have talked to key decision-makers and experts, exclusively analyzed FDA enforcement trends and provided a trusted, in-depth look at compliance challenges, inspections, warning letters, adverse event reporting and much more.
      PubDate: Mon, 16 Mar 2015 00:00:00 -040
  • PODCAST: 7 Best Practices For Effective Risk Management
    • Abstract: Online-Only Content >>> Larry Kopyta, VP of QA/RA for Pittsburgh-based device manufacturer Omnyx, offers tips to keep risk management programs healthy in this "Silver Sheet" podcast.
      PubDate: Fri, 13 Mar 2015 10:45:00 -040
  • Robotic Surgery Device Workshop Planned
    • Abstract: FDA will hold a two-day public workshop this summer to talk about clinical and regulatory issues surrounding robot-assisted surgical devices.
      PubDate: Thu, 12 Mar 2015 12:30:05 -040
  • Health Canada Will Regulate Reprocessors Beginning In January
    • Abstract: Health Canada will begin regulating commercial reprocessors of single-use medical devices next year, the regulatory body announced in a notice to reprocessing firms. Commercial reprocessors that provide services to Canadian hospitals or sell in that country are largely, if not exclusively, based in the U.S.
      PubDate: Thu, 12 Mar 2015 12:30:04 -040
  • Warning Letter Roundup & Recap
    • Abstract: Inovo didn't determine a root cause after reports of pulse malfunction troubles with certain lines of oxygen conservers; poor CAPA procedures and corrective actions cause problems at XZeal Technologies; Craftmatic Industries cited for MDR troubles; and more. Four warning letters were listed by FDA from Feb. 18 through March 12.
      PubDate: Thu, 12 Mar 2015 12:30:04 -040
  • Recent Warning Letter Close-Outs
    • Abstract: Two FDA close-out letters were released from Feb. 18 through March 12.
      PubDate: Thu, 12 Mar 2015 12:30:03 -040
  • Planning Board Urges FDA To Launch Postmarket Incubator Project
    • Abstract: FDA and its collaborators should launch an incubator project with fact-finding activities and pilot programs to help launch a national postmarket surveillance system that builds on Unique Device Identifiers (UDIs), registries, and innovative data capture and analysis strategies, a multi-stakeholder planning board recommends
      PubDate: Thu, 12 Mar 2015 12:30:02 -040
  • 4 Reasons Why Your Firm Should Use A Single-Audit Program
    • Abstract: Health Canada veteran and International Medical Device Regulators Forum participant Don Boyer urges medical device manufacturers to take IMDRF's Medical Device Single Audit Program seriously.
      PubDate: Thu, 12 Mar 2015 12:30:00 -040
  • Supply Chain Security Targeted By Draft Legislation – But How
           Burdensome Might It Be' Experts Weigh In
    • Abstract: Online-Only Content >>> In an effort to boost the safety and security of supply chains for finished prescription devices, the House Energy & Commerce Committee has proposed legislation that calls for the licensing of wholesale distributors and third-party logistics providers. Specifically, the "Device Distribution Licensing Act" – in the fifth and final section of the draft "21st Century Cures Act" – looks to curb the number of stolen and counterfeit products by requiring distributors and TPLs to be accredited by state or federal agencies by January 2016.
      PubDate: Wed, 18 Feb 2015 13:35:02 -050
  • Recent Warning Letter Close-Outs
    • Abstract: Eight quality-related FDA close-out letters were released from Jan. 15 through Feb. 18.
      PubDate: Wed, 18 Feb 2015 13:30:04 -050
  • Warning Letter Roundup & Recap
    • Abstract: FDA directs Verichem Labs to hire a consultant to help fix quality system troubles; ungloved employees were observed assembling sterile and non-sterile convenience kits at Customed; specification developer Praxair didn't ensure that quality data was analyzed; and more. Six quality-related warning letters were listed by FDA from Jan. 15 through Feb. 18.
      PubDate: Wed, 18 Feb 2015 13:30:04 -050
  • CDRH Appoints Public Health Expert To Lead Post-Market Surveillance Reform
    • Abstract: Gregory Pappas was appointed associate director for National Device Surveillance, a newly established title within CDRH's Office of Surveillance and Biometrics. Papas has been a central figure in public health, including HIV/AIDS policy-setting, for the previous 25 years, but he has not focused specifically on device regulation in the past.
      PubDate: Wed, 18 Feb 2015 13:30:03 -050
  • Companion Guidance For Combo Products Rule Clears Up Some Gray Areas
    • Abstract: The draft guidance provides real-world application, examples and detailed instructions for compliance with agency good manufacturing practice rules for drug delivery devices and other drug/device, drug/biological and drug/device/biological products.
      PubDate: Wed, 18 Feb 2015 13:30:02 -050
  • FDA Chief Heads For Door; Agency's Chief Scientist Will Fill Role –
           For Now
    • Abstract: FDA Commissioner Margaret Hamburg will step down at the end of March.
      PubDate: Wed, 18 Feb 2015 13:30:01 -050
  • Maquet Signs Consent Decree With FDA
    • Abstract: Device-maker Maquet enters into consent decree with FDA to stop making and distributing some hernia mesh, vascular graft and vascular patch products.
      PubDate: Wed, 18 Feb 2015 13:30:01 -050
  • Potential Benefits Of MDSAP Pilot Audits, By Jurisdiction
    • Abstract: What will an MDSAP audit get you? Here are the answers at different spots around the world, according to participating regulatory authorities.
      PubDate: Wed, 28 Jan 2015 12:15:13 -050
  • 10 Inspection Questions Answered By 3 FDA Investigators
    • Abstract: Online-Only Content >>> FDA National Device Expert and investigator Phil Pontikos, along with fellow investigators Marc Neubauer and Lori Lawless from the agency's Baltimore district office, answer ten queries from medical device manufacturers.
      PubDate: Wed, 28 Jan 2015 12:15:01 -050
  • 10 Key Things To Know About The Medical Device Single-Audit Program
    • Abstract: Online-Only Content >>> After a long build up, four international regulatory authorities officially rolled out the Medical Device Single Audit Program pilot this month. Here are 10 things that FDA wants manufacturers to know about the program.
      PubDate: Wed, 28 Jan 2015 12:15:00 -050
  • PODCAST: 5 Things Every QA/RA Professional Should Keep An Eye On In 2015
    • Abstract: Online-Only Content >>> In this "Silver Sheet" podcast, quality/regulatory expert Christine Santagate reads the tea leaves on five hot industry topics that will unfold over the year.
      PubDate: Wed, 21 Jan 2015 16:00:00 -050
  • CDRH Compliance Director Steven Silverman Departing
    • Abstract: Online-Only Content >>> Steven Silverman is leaving FDA to pursue other opportunities outside of government. "I’ve never had a better job than my current one. Even so, I feel that it’s time for me to gain experience in other areas," said Silverman, who has not signaled what his next move will be.
      PubDate: Wed, 14 Jan 2015 17:45:01 -050
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