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Journal Cover   The Silver Sheet
  [3 followers]  Follow
   Full-text available via subscription Subscription journal
   ISSN (Print) 1068-5324
   Published by Informa plc Homepage  [15 journals]
  • A Long, Twisted Path To Revision: How The 'Unusual' Makeover Of ISO 13485
           Will Impact Device Manufacturers – And Why There Isn't Much They Can
           Do About It Now
    • Abstract: Staying the course has been an ongoing challenge for the International Organization for Standardization as it works overtime to revise ISO 13485, one of the most widely used quality system standards in medical device manufacturing. There have been obstacles to the latest revision of ISO 13485: some ISO member-countries voted against drafts of the standard for no apparent reason; an inordinate number of industry comments had to be reviewed one-by-one; and the document's redo bumped up against the revision of an even bigger, broader international standard, ISO 9001 – just to name a few headaches...
      PubDate: Thu, 20 Aug 2015 13:20:01 -040
  • New FDA Crackdown On Duodenoscope Makers Includes Warning Letters, 510(k)
           Status Alerts
    • Abstract: FDA takes new enforcement actions against duodenoscope makers in Aug. 12 warning letters to Fujifilm Medical Systems, Hoya and Olympus Medical Systems, charging adulterations to scopes, and noting troubles with CAPAs and reprocessing validation activities. Meanwhile, Fujifilm and Hoya also received so-called "510(k) status" letters.
      PubDate: Mon, 17 Aug 2015 18:35:01 -040
  • Electronic Medical Device Reporting Is Now Mandatory – Is Your Firm
    • Abstract: Although there will be a grace period for eMDR, FDA will return paper-based adverse event reports to manufacturers after Sept. 15. CDRH's Isaac Chang explains.
      PubDate: Fri, 14 Aug 2015 11:00:00 -040
  • Visual Podcast: FDA & Complaints – Your Achilles Heel
    • Abstract: In his third "Gray Sheet" podcast appearance, former FDA official Cap Uldriks offers manufacturers tips and advice to ensure that complaint handling systems are healthy and stay that way.
      PubDate: Mon, 10 Aug 2015 13:15:00 -040
  • From MDR to CAPA: 6 Questions Answered By FDA Investigators
    • Abstract: FDA investigators offer tips and warnings related to Medical Device Reporting, device complaints, the role of 510(k) status in an inspection, IVD considerations, and the path to a warning letter in the latest Compliance Corner column.
      PubDate: Mon, 06 Jul 2015 16:30:00 -040
  • In-Depth With CDRH Compliance Chief: Jan Welch Trumpets 'Case For
           Quality,' Urges Feedback From Manufacturers
    • Abstract: This "Silver Sheet"/"Gray Sheet" Q&A with Jan Welch, interim director of CDRH's Office of Compliance, offers a glimpse into current device center thinking on various activities such as FDA's "Case for Quality." She also warns device manufacturers that if they don't speak up, some issues of importance to them could end up on the back burner. And: Is Welch interested in the job full time?
      PubDate: Mon, 29 Jun 2015 12:30:00 -040
  • Snapshot: Overall Medical Device Recalls Inched Up In 2014; High-Risk
           Class I's Flat
    • Abstract: Medical device recall trends remained relatively unchanged last year despite a slight increase in overall corrections and removals, a "Silver Sheet" analysis finds. Plus: a tally of high-risk class I recalls and a top 5 listing of manufacturers that recalled the most products last year.
      PubDate: Mon, 08 Jun 2015 13:55:01 -040
  • Compilation: 2014 Medical Device Recalls
    • Abstract: A sortable and searchable table of recalls from calendar year 2014. The upshot: there were 62 class I (5%), 1,078 class II (91%) and 46 class III (4%) medical device events last year.
      PubDate: Mon, 08 Jun 2015 13:45:02 -040
  • Warning Letter Roundup & Recap – June 2, 2015
    • Abstract: Employees tasked with reviewing quality audits at Soft Computer Consultants weren't trained on the current version of the firm's audit approval procedure; maker of intra-aortic balloon catheters and inguinal hernia implants cited for QS and MDR reg violations; and more. Four device warning letters were listed by FDA this week.
      PubDate: Wed, 03 Jun 2015 14:00:02 -040
  • Warning Letter Close-Outs – May 2015
    • Abstract: FDA released five close-out letters in May.
      PubDate: Fri, 29 May 2015 12:30:00 -040
  • Warning Letter Roundup & Recap – May 26, 2015
    • Abstract: Six reportable adverse events went uninvestigated at Battle Creek Equipment because the firm only reviewed complaints related to returned product; Signal Medical made changes to its MicroSeal Total Hip Acetabular System that required a new 510(k); and more. Two device warning letters were listed by FDA this week.
      PubDate: Wed, 27 May 2015 14:00:05 -040
  • Warning Letter Roundup & Recap – May 19, 2015
    • Abstract: After evaluating information gathered during an FDA inspection and reviewing ZYTO Technologies' website, the agency discovered that the firm promoted its device for functions outside its cleared intended use; MicroAire had no internal systems for determining whether an event was MDR-reportable; and more. Two warning letters were listed by FDA this week.
      PubDate: Tue, 19 May 2015 14:40:02 -040
  • Warning Letter Roundup & Recap – May 12, 2015
    • Abstract: Anybattery Inc. sold replacement batteries without premarket approval or clearance from FDA; EMcision used electronic signatures to approve numerous procedures despite not having electronic signature systems; and more. Three warning letters were listed by FDA this week.
      PubDate: Tue, 12 May 2015 16:00:00 -040
  • UDI Goes Public: Beta Device Identifier Database Now Online
    • Abstract: FDA has launched the beta version of AccessGUDID as the publicly available face of the Global Unique Device Identification Database. As of May 4, there are 48,093 device records in the searchable system.
      PubDate: Tue, 05 May 2015 17:30:01 -040
  • Warning Letter Roundup & Recap – May 5, 2015
    • Abstract: Smith & Nephew places hold on shipments of Truclear Ultra Reciprocating Morcellators while the firm further investigates problems with the device; maker of medical support stockings didn't evaluate suppliers of fabric, yarn and thread; and more. Three device warning letters were listed by FDA this week.
      PubDate: Tue, 05 May 2015 15:05:00 -040
  • Boston Scientific Uses Risk-Based Process To Swiftly Identify, Correct
           Problem Devices
    • Abstract: The manufacturer's path to a company-wide risk management program was a tough row to hoe after it was issued an FDA corporate warning letter in 2006. But now its quality system is back on track and the firm is finding it easier than ever to deal with nonconforming product by using a risk-based process that involves layers of professional review, the firm's VP of global quality systems says.
      PubDate: Mon, 04 May 2015 14:00:00 -040
  • ‘Cures’ Plan To Rely On 3rd-Party Audits For Some Device
           Changes Needs Tweaks, Shuren Says
    • Abstract: Reliance upon a third-party assessment of quality systems for certain device modifications might eventually help industry, but it would “probably not” be efficient for FDA’s device center, as proposed in the House 21st Century Cures effort.
      PubDate: Thu, 30 Apr 2015 18:00:06 -040
  • Warning Letter Close-Outs – April 2015
    • Abstract: Ten FDA close-out letters were released in April.
      PubDate: Thu, 30 Apr 2015 12:00:01 -040
  • Warning Letter Roundup & Recap – April 28, 2015
    • Abstract: Complaints weren't evaluated and investigated at Applied Medical Resources, including two reports of death related to its Kii Shield Bladed System; Natus Medical didn't notify FDA after it sent three technical bulletins to customers to make changes to neoBLUE devices; and more. Two device warning letters were listed by FDA this week.
      PubDate: Tue, 28 Apr 2015 15:55:01 -040
  • Warning Letter Roundup & Recap – April 21, 2015
    • Abstract: FDA wasn't notified after Thermedx made 21 software upgrades to devices in the field; manufacturer of air filters and spirometers failed to analyze quality data; and more. Six device warning letters were listed by FDA this week.
      PubDate: Fri, 24 Apr 2015 11:45:01 -040
  • Visual Podcast: 9 Risk Management Questions Firms Should Ask When Making
           Design Changes
    • Abstract: Changes to international standard ISO 13485 are coming – are you ready? Steris' Bill Brodbeck talks about how the revised standard will require more risk management activities, and he encourages manufacturers to ask themselves nine questions related to risk when making device changes in this "Silver Sheet" visual podcast.
      PubDate: Thu, 23 Apr 2015 11:00:01 -040
  • Visual Podcast: 'System Of Quality' Approach Is Shot In Arm For
           Conventional QMS, Eli Lilly Quality Leader Explains
    • Abstract: Manufacturers that implement a so-called "system of quality model" will be best suited to assess traditional quality management systems in preparation for even more digital devices reaching the market, an Eli Lilly global quality leader says in this "Silver Sheet" visual podcast.
      PubDate: Tue, 21 Apr 2015 11:00:01 -040
  • Warning Letter Roundup & Recap – April 14, 2015
    • Abstract: Employees weren't trained in GMP, quality, CAPA and manufacturing equipment procedures at Visionary Contact Lens; maker of air filters and spirometers cited for quality system reg violations; and more. Three device warning letters were listed by FDA this week.
      PubDate: Thu, 16 Apr 2015 21:50:01 -040
  • First Firm Audited Under MDSAP Urges Companies To Pay Closer Attention To
           International Regs
    • Abstract: Orthopedic device manufacturer Arthrex was the inaugural auditee of IMDRF's Medical Device Single Audit Program. During the inspection it was dinged by auditors when the company wasn't wholly familiar with Australian regulatory requirements.
      PubDate: Fri, 10 Apr 2015 15:20:02 -040
  • European Union Finally Joins MDSAP Work Group – But Only As
    • Abstract: The European Commission sent representatives to a March 23 meeting related to IMDRF's Medical Device Single Audit Program. But for now they'll only be observing, FDA's Kim Trautman says.
      PubDate: Wed, 08 Apr 2015 17:20:00 -040
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