Navigation Links
Delcath's Ireland Operations Achieves ISO 13485 Certification
Date:12/28/2011

NEW YORK, Dec. 28, 2011 /PRNewswire/ --Delcath Systems, Inc. (NASDAQ: DCTH) today announced that the Company's Galway, Ireland location has achieved ISO 13485:2003 Certification—an internationally recognized quality standard designed to ensure that medical device manufacturers have the necessary comprehensive quality management systems in place to safely design, develop, manufacture and distribute medical devices in the European Union (EU). ISO 13485 Certification is a regulatory requirement of the EU's Medical Device Directive, and represents an important step toward commercialization of the Delcath Hepatic CHEMOSAT® Delivery System following its European CE Mark approval in April 2011.

"ISO 13485 Certification of our Galway facility confirms that our manufacturing and quality systems meet the high standards required of medical device companies selling into Europe," said Eamonn P. Hobbs, CEO & President of Delcath Systems.  "This achievement represents one more important milestone toward commercialization of CHEMOSAT in the EU, and we are looking forward to a successful initial launch of the product early next year."

About Delcath SystemsDelcath Systems, Inc. is a development stage specialty pharmaceutical and medical device company focused on oncology. Delcath's proprietary system for chemosaturation is designed to administer high dose chemotherapy and other chemotherapeutic agents to diseased organs or regions of the body, while controlling the systemic exposure of those agents. The Company's initial focus is on the treatment of primary and metastatic liver cancers. In 2010, Delcath concluded a Phase III metastatic melanoma study, and the Company recently completed a multi-arm Phase II trial to treat other liver cancers. The Company obtained authorization to affix a CE Mark for the Hepatic CHEMOSAT Delivery System in April 2011. The C
'/>"/>

SOURCE Delcath Systems, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Beckman Coulter Announces Licensing Agreements for Molecular Tests with National University of Ireland, Galway
2. Misonix Announces New Distribution Agreement for United Kingdom and Republic of Ireland
3. Tunnell Consulting Forms Strategic Alliance With Ireland-Based Campbell Informatics
4. Pioneer® Surgical Technology, Inc. Announces Plans to Establish Manufacturing and Distribution Facility in Ireland
5. American Scientific Resources Announces New Distributor Syner-Med Placing Kidz-Med VeraTemp in the United Kingdom and Ireland
6. BioMarin Agrees to Acquire Biologics Manufacturing Plant in Ireland from Pfizer
7. ReportsnReports - Cardiovascular Devices Investment Opportunities, Analysis & 2017 Forecasts: Greece, Hungary, Ireland
8. Innocoll Provides a Progress Update on its Clinical Development Programs and Specialty Pharmaceutical Operations
9. Anesiva Announces Adlea ACTIVE-1 Phase 3 Clinical Results, Ceasing of Zingo Commercial Operations and Restructuring
10. Premier Research Expands its Medical Device Operations to the United States
11. Caraco Pharmaceutical Laboratories, Ltd. Enters Into Consent Decree with FDA Providing Path to Resume Manufacturing Operations
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/29/2014)... /PRNewswire-iReach/ -- SAM Medical Products Implements Voluntary Recall ... Junctional Tourniquet.  Photo - ... announced today that it has begun notifying customers ... issue with a clip used to secure the ... the SAM Junctional Tourniquet (SJT).  The company discovered ...
(Date:8/29/2014)... , Aug. 29, 2014   Mast Therapeutics, ... company, announced today that Santosh Vetticaden, Chief Medical ... the Company, for personal reasons, in mid-September.  ... Officer of Aires Pharmaceuticals, which Mast acquired earlier ... as the Company,s interim Chief Medical Officer.  Dr. ...
(Date:8/29/2014)... 29, 2014  BC Technical, the nation,s leading non-OEM ... Imaging, a leader in sales, service and installation of ... BC Technical to continue to expand their resources and ... CT modalities. "We are committed to ... Alvarez , president and CEO of BC Technical. "We ...
Breaking Medicine Technology:SAM Medical Products Implements Voluntary Recall of its Accessory (Axilla) Strap for the SAM Junctional Tourniquet. 2Mast Therapeutics Announces Management Change 2Mast Therapeutics Announces Management Change 3Mast Therapeutics Announces Management Change 4BC Technical Acquires Polaris Medical Imaging 2
... Open-label Extension of Phase II Study Demonstrates ... Mass., June 12, 2007 /PRNewswire-FirstCall/ --,Indevus Pharmaceuticals, ... Phase II EXPRESS trial for pagoclone in ... the 47th annual,meeting of the New Clinical ...
... activity reported against CTCL, PTCL and Ovarian ... -- CuraGen,Corporation , a clinical-stage biopharmaceutical company ... the clinical development,program for belinostat, a histone ... clinical activity of belinostat,against cutaneous T-cell lymphoma ...
Cached Medicine Technology:Indevus Announces Presentation of Pagoclone Data at 47th Annual New,Clinical Drug Evaluation Unit Meeting 2Indevus Announces Presentation of Pagoclone Data at 47th Annual New,Clinical Drug Evaluation Unit Meeting 3Indevus Announces Presentation of Pagoclone Data at 47th Annual New,Clinical Drug Evaluation Unit Meeting 4Indevus Announces Presentation of Pagoclone Data at 47th Annual New,Clinical Drug Evaluation Unit Meeting 5Indevus Announces Presentation of Pagoclone Data at 47th Annual New,Clinical Drug Evaluation Unit Meeting 6Indevus Announces Presentation of Pagoclone Data at 47th Annual New,Clinical Drug Evaluation Unit Meeting 7Indevus Announces Presentation of Pagoclone Data at 47th Annual New,Clinical Drug Evaluation Unit Meeting 8Indevus Announces Presentation of Pagoclone Data at 47th Annual New,Clinical Drug Evaluation Unit Meeting 9CuraGen Presents Update on Clinical Development Program for,Belinostat 2CuraGen Presents Update on Clinical Development Program for,Belinostat 3CuraGen Presents Update on Clinical Development Program for,Belinostat 4CuraGen Presents Update on Clinical Development Program for,Belinostat 5CuraGen Presents Update on Clinical Development Program for,Belinostat 6CuraGen Presents Update on Clinical Development Program for,Belinostat 7CuraGen Presents Update on Clinical Development Program for,Belinostat 8
(Date:8/30/2014)... (PRWEB) August 30, 2014 Serving contented ... in India, Profit By Outsourcing is now offering ... services. The company gives emphasize on putting forward the ... product to clients. Their dedicated team of professionals and ... results. They can handle even the critical issues of ...
(Date:8/30/2014)... 30, 2014 "I had a handicapped friend ... crutches," said an inventor from Wetumpka, Ala. "In order to ... of the shore, I came up with a way for ... created a prototype for the patent-pending Deezers to allow crutches ... individual to use crutches, walkers, or canes at the beach. ...
(Date:8/30/2014)... (PRWEB) August 30, 2014 In today’s ... and increasingly difficult to get. Snoring and sleep apnea ... and breathing stops) robs people and their bed partners ... challenges. Up to 45% of the population snores and ... sleep apnea. Of these, only 10% have been diagnosed ...
(Date:8/30/2014)... The new review published by Daily Gossip ... Karen Brimeyer, who wanted to make her guide accessible to ... is now easy to find in the form of an ... the author of the new method shares all her tips ... writes in its review that the leaky gut syndrome can ...
(Date:8/30/2014)... 2014 LiveStreamingFitness.com, a company dedicated to providing ... lifestyle resources, is proud to announce it has been recognized ... home fitness solutions by ABC’s Good Morning America. ... ABC’s Good Morning America, “Live Streaming Fitness is the hottest ... day by streamlining your workout…to boot camp at Life Streaming ...
Breaking Medicine News(10 mins):Health News:Profit By Outsourcing Offering Discount for Labor Day on all Web Development Services 2Health News:Snoring: Bad for Relationships, Bad for Health 2Health News:Snoring: Bad for Relationships, Bad for Health 3Health News:Leaky Gut Cure Review Reveals Unique Method to Stop Chronic Symptoms 2Health News:LiveStreamingFitness.com is New Trend In Fitness 2
... System for Rapid Testing for Infectious Diseases Incorporates the ... ARBOR, Mich., May 18 BD Diagnostics, a segment ... BDX ), and HandyLab, Inc. announced today that they ... commercialize its molecular assays on a new BD MAX(TM) ...
... Payment Support Insurance Industry Corporate GreeningSAN DIEGO and ... a leading provider of medical cost containment, provider ... over 70% of U.S. automotive insurance payers, and ... and Gateway Services to Workers, Compensation, Auto Medical ...
... be presented on Abbott,s market-leading XIENCE V(R) stent- Educational ... stent in developmentBARCELONA, Spain, May 18 Abbott (NYSE: ... of major events and news announcements during EuroPCR 2009 ... presentation of new data from the SPIRIT V post-approval, ...
... and PrEP Research and Calls for Urgent Coordination and Leadership ... "It,s an exciting time in HIV prevention research. We will ... research trials this year, as well as see the start ... answers in the years to come," said Mitchell Warren, AVAC ...
... SAN DIEGOCystic fibrosis patients may benefit from a new ... mucous, which is a key factor in the disease, ... The research will be presented on Sunday, May 17, ... San Diego., "Our results suggest that we have identified ...
... help physicians solve a perennial problem: patients who don,t ... the Kaiser Permanente Center for Health Research, in Portland, ... patients with asthma to fill or refill their prescriptions ... be presented on May 17 at the 105th International ...
Cached Medicine News:Health News:BD and HandyLab Announce Exclusive Collaboration to Commercialize Molecular Assays 2Health News:BD and HandyLab Announce Exclusive Collaboration to Commercialize Molecular Assays 3Health News:BD and HandyLab Announce Exclusive Collaboration to Commercialize Molecular Assays 4Health News:Mitchell and Jopari Say 'Green Transaction Initiatives' Play Key Role in P&C and Group Health Industry Environmental Best Practices 2Health News:Mitchell and Jopari Say 'Green Transaction Initiatives' Play Key Role in P&C and Group Health Industry Environmental Best Practices 3Health News:Mitchell and Jopari Say 'Green Transaction Initiatives' Play Key Role in P&C and Group Health Industry Environmental Best Practices 4Health News:Abbott Announces EuroPCR 2009 Activities 2Health News:Abbott Announces EuroPCR 2009 Activities 3Health News:Abbott Announces EuroPCR 2009 Activities 4Health News:Piecing Together the HIV Prevention Puzzle 2Health News:Piecing Together the HIV Prevention Puzzle 3Health News:Piecing Together the HIV Prevention Puzzle 4Health News:Sodium channel blocker shows promise as a potential treatment for cystic fibrosis 2Health News:Increasing ICS compliance: The voice may be recorded, but the results are real 2Health News:Increasing ICS compliance: The voice may be recorded, but the results are real 3
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
Medicine Products: