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iso in Medical News

Established Medical Sub-Component Manufacturer Achieves ISO 13485 Certification

AVON, Conn., July 28 /PRNewswire/ -- OFS, Specialty Photonics Division, today announces its Avon facility's certification to the international management system standard ISO 13485, as verified by Bureau Veritas Certification. All OFS Specialty Photonics Division facilities have mainta...

DST Health Solutions Achieves ISO 9001:2008 Certification

BIRMINGHAM, Ala., July 28 /PRNewswire/ -- DST Health Solutions, a leading provider of software and services to health plans and physician practices, has achieved ISO 9001:2008 certification, a designation demonstrating its commitment to quality product development. DST Health S...

Misonix Subsidiary, Sonora Medical Systems, Achieves ISO 17025 Accreditation

FARMINGDALE, N.Y., June 18 /PRNewswire-FirstCall/ -- Misonix, Inc. (Nasdaq: MSON ), a developer of minimally invasive ultrasonic medical device technology, which in Europe is used for the ablation of tumors and worldwide for other acute health conditions, announced today that its subsidiary, Son...

Biomerix Corporation Receives ISO 13485 Certification

Company with Innovative Biomaterial Technology Achieves Significant Milestone in CE Mark Approval Pathway FREMONT, Calif., June 15 /PRNewswire/ -- Biomerix Corporation, a medical technologies company developing products using its novel Biomerix Biomaterial(TM), a three-dimensional scaffold fo...

Optasia Medical, Ltd. Achieves ISO 9001 and ISO 13485 Certification

CHEADLE, England and SUDBURY, Massachusetts, May 11 /PRNewswire/ -- Optasia Medical Ltd., a maker of model-based vision software for musculoskeletal radiography has received certification for the successful registration of our quality management system to both ISO 9001:2008 and ISO 13485:2003....

Neuro Kinetics Earns ISO 13485 Certification

'Demonstrates Unwavering Commitment to Quality' for Company's Medical Devices PITTSBURGH, May 4 /PRNewswire/ -- Neuro Kinetics, Inc. (NKI) ( www.neuro-kinetics.com ), manufacturers of noninvasive medical evaluation equipment used worldwide to test for balance, vestibular, neurological and o...

TRICOR Systems Inc. Receives ISO 13485 Certification; Contract Manufacturer Achieves Another Significant Milestone in 32 Year History

TRICOR Systems Inc. announced that it had received an ISO 13485 Certificate of Registration issued by NSAI (National Standards Authority of Ireland). The certification ads to TRICOR's previous certifications and FDA registration. Elgin, IL. (PRWEB) April 8, 2009 -- TRIC...

CSOFT Earns ISO 13485:2003 Certification for Medical Device Industry

Certification Confirms MedL10N Division's Commitment to Quality Beijing, China (PRWEB) March 31, 2009 -- CSOFT International Ltd., a leading provider of multilingual localization, testing and outsourced software development for the global market, announced today that it...

Lionbridge Receives ISO 13485:2003 Certification for Quality Management

Certification Underscores Lionbridge's Market-Leading Translation Management Program for Life Sciences Organizations Worldwide WALTHAM, Mass., March 10 /PRNewswire-FirstCall/ -- Lionbridge (Nasdaq: LIOX ) today announced that it recently received ISO 13485:2003 certification which verifies ...

Osteotech Receives 13485:2003 ISO Certification; Company Meets International Standards for Medical Device Manufacturing

EATONTOWN, N.J., Feb. 19 /PRNewswire-FirstCall/ -- Osteotech, Inc. (Nasdaq: OSTE ), a leader in the emerging field of biologic products for regenerative healing, announced today that it has received ISO 13485:2003 certification for its quality management system. Osteotech received ISO certificat...

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iso in Medical Technology

Cryo-Cell Announces C'elle(SM) Research and Development Collaboration with Cryopraxis Cryobiology Ltd.

....OB) Based in Oldsmar, Florida, with nearly 185,000 clients worldwide, Cryo-Cell is one of the largest and most established family cord blood banks. iso 9001:2000 certified and accredited by the AABB, Cryo-Cell operates in a state-of-the-art Good Manufacturing Practice and Good Tissue Practice (cGMP/cG...

TYRX Presents Early Clinical Results from AIGISRX(TM) Antibacterial Envelope Retrospective Registry

...can be found at www.TYRX.com . About TYRX, Inc. TYRX, Inc., an iso 9001:2000 and iso 13485:2003 certified medical device manufacturer, commercializes implantabl...

Facet Solutions, Inc. Expands U.S. Pivotal Study With Next Generation Implant System

...enture capital from its partners DeNovo Ventures, FirstMark Capital, and Spray Venture Partners. Facet Solutions is FDA registered and is certified to iso 13485. www.facetsolutions.com ...

Verification Studies of IntelligentMDx's Proprietary Molecular Diagnostic Assay Process Have Been Completed

...ed diagnostic kits. To guarantee quality for customers and partners we design, develop and manufacture tests under FDA Quality System Regulations and iso 13485:2003 guidelines. These tests have been, and will be, designed to run on a broad range of molecular systems for clinical diagnostics, drug develo...

Facet Solutions Announces Completion of 6 Month Follow-Up in US Pilot Study

...olutions has received venture capital from its partners De Novo Ventures, Pequot Ventures, and Spray Venture Partners. Facet Solutions is certified to iso 13485. The company will be attending the upcoming North American Spine Surgeons Meeting in Toronto, Ontario (booth #1406). ...

Going Beyond 'Spa Day': Giving Women the Opportunity to Do Something Proactive Which May Lead to Long Term Health Benefits

... CCEL) Based in Oldsmar, Florida, with over 155,000 clients worldwide, Cryo-Cell is one of the largest and most established family cord blood banks. iso 9001:2000 certified and accredited by the AABB, Cryo-Cell operates in a state-of-the-art Good Manufacturing Practice and Good Tissue Practice (cGMP/cG...

AstraZeneca Announces Innovative New Partnership With Singapore Institutions to Develop Anti-Cancer Compounds

...n, an international stamp for excellent clinical practices in patient care and safety. It was also the first hospital in Singapore to receive a triple iso certification concurrently for Quality, Environmental, and Occupational Health & Safety Management Systems in 2002. Manchester Cancer Research Centr...

Sahajanand Medical Technologies PAINT Trial Results Support Safety and Efficacy of the Infinnium and Supralimus Stents

...pments. The products are manufactured conforming to the international quality standards and are offered at the most competitive prices. The Company is iso 9000 certified & also obtained CE certification for its advanced range of products. This gives assurance of company's quality consciousness. For more ...

New Study Confirms Dose-Accuracy of SoloSTAR(R) Prefilled Insulin Pen

...ltiple target dosages to determine the proportion of doses that fell within iso ranges. "For people with diabetes who use an insulin pen to deliver their...s was randomized. All doses (100%) were within the limits prescribed by the iso standard (mean doses were only 0.9% to 1.3% below targets for Lantus(R), an...

Early Research Suggests Umbilical Cord Blood Cell Therapy May Reduce Progression of Alzheimer's Disease

...EL.OB) Based in Oldsmar, Florida, with over 150,000 clients worldwide, Cryo-Cell is one of the largest and most established family cord blood banks. iso 9001:2000 certified and accredited by the AABB, Cryo-Cell operates in a state- of-the-art Good Manufacturing Practice and Good Tissue Practice (cGMP/c...

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iso in Medical Products

R4Mplus Printer

Description:...guage font support, the R4Mplus is a super value. Plus, the fully integrated RFID reader/encoder supports a number of tag types, including EPC UHF and iso 18000-6B UHF protocols. With products available in both North America and Europe, the R4Mplus offers configurations that can meet regional RFID regula...
Company:Zebra Technologies Corporation

R4Mplus

Description:...guage font support, the R4Mplus is a super value. Plus, the fully integrated RFID reader/encoder supports a number of tag types, including EPC UHF and iso 18000-6B UHF protocols. With products available in both North America and Europe, the R4Mplus offers configurations that can meet regional RFID regula...
Company:Zebra Technologies Corporation

Bivona® HME Soft

Description:...ll as adults. With a high rate of heat and moisture recovery, it ensures patient comfort and reduces secretion retention. All HMEs and filters have iso standard tapered ends to assure a consistent leak-free seal. All Portex® HMEs and filters are latex-free....
Company:Portex

Thermovent® T HME

Description:...ll as adults. With a high rate of heat and moisture recovery, it ensures patient comfort and reduces secretion retention. All HMEs and filters have iso standard tapered ends to assure a consistent leak-free seal. All Portex® HMEs and filters are latex-free....
Company:Portex

Thermovent® 600 HME

Description:...ll as adults. With a high rate of heat and moisture recovery, it ensures patient comfort and reduces secretion retention. All HMEs and filters have iso standard tapered ends to assure a consistent leak-free seal. All Portex® HMEs and filters are latex-free....
Company:Portex

Thermovent® 1200 HME

Description:...ll as adults. With a high rate of heat and moisture recovery, it ensures patient comfort and reduces secretion retention. All HMEs and filters have iso standard tapered ends to assure a consistent leak-free seal. All Portex® HMEs and filters are latex-free....
Company:Portex

HME with Gas Sampling Port

Description:...ll as adults. With a high rate of heat and moisture recovery, it ensures patient comfort and reduces secretion retention. All HMEs and filters have iso standard tapered ends to assure a consistent leak-free seal. All Portex® HMEs and filters are latex-free....
Company:Portex

HME with Flex Tube

Description:...ll as adults. With a high rate of heat and moisture recovery, it ensures patient comfort and reduces secretion retention. All HMEs and filters have iso standard tapered ends to assure a consistent leak-free seal. All Portex® HMEs and filters are latex-free....
Company:Portex

HME

Description:...ll as adults. With a high rate of heat and moisture recovery, it ensures patient comfort and reduces secretion retention. All HMEs and filters have iso standard tapered ends to assure a consistent leak-free seal. All Portex® HMEs and filters are latex-free....
Company:Portex

Pulmonary Function Test Filter

Description:...ll as adults. With a high rate of heat and moisture recovery, it ensures patient comfort and reduces secretion retention. All HMEs and filters have iso standard tapered ends to assure a consistent leak-free seal. All Portex® HMEs and filters are latex-free....
Company:Portex

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iso in Biological News

Validus and HierStar Form Strategic Alliance to Offer the First Complete Range of Authentication Products

...c powered card that generates an OTP at the push of a button. This card is iso 7810 compliant to support payment cards and many other market applications....ircuit boards, components and displays, as well as molding technologies for iso standard cards. HierStar supplies OEMs with displays, and ready to laminate...

CEL-SCI Corporation to Launch Aseptic Filling for Stem Cell Produced Therapies and Other Biological Products

...d at temperatures between 2 degrees Celsius and room temperatures, including humidity control. The Aseptic filling suites are maintained at FDA and EU iso classifications of 5/6. CEL-SCI also has additional capability to formulate, inspect, label and package these products at cold temperatures. "We...

First fuel-handling facility in the Galapagos earns environmental certification

...llion refined the facilities' environmental management system allowing it to attain official certification. Today the facility was awarded official iso 14001 certification by the Bureau Veritas Certification, a third-party certification body, verifying that the facility is environmentally sound. "...

BIO-key(R) to Showcase Biometric Security Applications at 2008 Biometric Technology Expo

...grated into any application or platform. With more than 400 million BIO-key iso fingerprint templates in use today, and over 16,000 digital enrollment stat...uccessfully delivered on time and on budget. Additionally, over 400 Million iso templates have now been generated by BIO-key software to date; the most in ...

Sony Cyber-shot Cameras Get Smarter

...e recognition technology, Smile Shutter(TM) and face detection technologies with child and adult priority, as well as high sensitivity shooting (up to iso 3200), eleven scene modes, and in-camera image management. The T700 model earns extra points as a "photo album in your pocket." It has all the featu...

Integral Vision, Inc. Announces SharpEye(TM) Order From New Customer

...omer," said Charles J. Drake, chairman and CEO of Integral Vision, Inc. About Integral Vision Integral Vision, Inc. (OTC Bulletin Board: INVI), an iso 9001 registered firm, offers display inspection technology that provides analysis of functional and cosmetic defects in the display to assure quality ...

Entrust Digital Signatures Help Secure More Than 18 Million U.S. ePassports

...initially being defined by the Brussels Interoperability Group (BIG) for use within Europe. Entrust actively is participating in BIG as well as in the iso Task Force on Security for ePassports. These next-generation ePassports, using EAC, will be required by all European Union (EU) Schengen member States...

Fidelica Microsystems Announces Biometrically-Authenticated Smart Card

...erprint imaging, enrollment and authentication contained entirely within an iso 7810/16-format smart card. This card offers a cost-effective and easy-to-us...d readers. -- Allows for ready migration to biometrics on smart cards with iso 14443 and other wireless protocols without installing fingerprint senso...

BIO-key(R) and Tiger IT Awarded a Follow-on Contract for Nationwide Voter / Citizen Registration in Bangladesh

...citizen to access up to 22 different services managed or offered by the government. The National ID card also includes a standard barcode encoded with iso fingerprint templates and PKI digital hash that can be used to quickly verify the identity of the cardholder and the integrity and authenticity of the...

BIO-key(R) International to Showcase Deployed Biometric Security Applications at 2007 Biometric Technology Expo

... fingerprint based authentication software solutions that can be easily integrated into any application or platform. With more than 80 million BIO-key iso fingerprint templates in use today, and over 16,000 digital enrollment stations deployed with the BIO-key software in a single project, BIO-key is a p...

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iso in Biological Technology

IlluminOss Medical Receives ISO 13485 Certification

Company with Innovative Technology for the Minimally Invasive Treatment of Bone Fractures Achieves Significant Milestone in CE Mark Approval Pathway EAST PROVIDENCE, R.I., Feb. 23 /PRNewswire/ -- IlluminOss Medical Inc., a medical device company developing the innovative IlluminOss(TM) Photod...

Victhom Human Bionics Neurobionix Division receives ISO 13485:2003 Certification for its Design Control System

QUEBEC, Jan. 23 /PRNewswire-FirstCall/ - Victhom Human Bionics Inc., "Victhom" (TSX: VHB), announced today that its Neurobionix division has achieved ISO 13485:2003 certification for its Quality System Design Control. This certification, an internationally recognized management system standard dev...

Level 3 Inspection Achieves 100% Compliance in ISO 9001 & AS 9100 Certification

JUPITER, Fla., Jan. 13 /PRNewswire/ -- Level 3 Inspection LLC (L3I) has successfully completed the Quality Management System (QMS) development by meeting or exceeding all of the requirements for ISO 9001 and AS 9100 Certification under the rules of the aerospace standard. L3I passed their ISO/...

Serica Technologies Receives ISO Certification, Meets International Standards for Medical Device Manufacturing

MEDFORD, Mass., Nov. 19 /PRNewswire/ -- Serica Technologies, Inc., a growth-stage medical device company developing silk-based biomaterial platforms for tissue regeneration, today announced that it has received ISO 13485:2003 certification, meeting stringent international quality standards require...

Valor Medical Closes $1.4 Million Convertible Debt and Receives ISO 13485 Certification

SAN DIEGO, Nov. 6 /PRNewswire/ -- Valor Medical, Inc., a medical device company that has developed a liquid embolic technology for the treatment of cerebral aneurysms, announced today that they have successfully raised $1.4 million in capital through a convertible debt offering. Valor's Chief ...

Cylex(TM) Receives ISO 13485:2003 and 9001:2000 Quality Certifications

ISO certification confirms implementation of quality systems in product design and development, manufacture, and distribution for Cylex's ImmuKnow(R) immune cell function assay COLUMBIA, Md., Oct. 1 /PRNewswire/ -- Cylex has announced receipt of certification to ISO 13485:200...

New England Peptide Implements Quality Management System, Prepares for ISO 9001: 2008 Registration

New England Peptide, LLC (NEP), is developing a formal quality management system at its Gardner, Mass., facility, focusing on continuous process improvement and customer satisfaction. Gardner, Mass. (PRWEB) July 15, 2008 -- New England Peptide, LLC (NEP), is developing ...

TraumaCure Receives Prestigious ISO 13485 Certification

TraumaCure Inc. – makers of the ground-breaking hemostatic agent, WoundStat™ – today announced that the company has received the prestigious international ISO 13485 certification for its quality system for design, development, production and sales of medical devices. The company...

TraumaCure Receives Prestigious ISO 13485 Certification

TraumaCure Inc. – makers of the ground-breaking hemostatic agent, WoundStat™ – today announced that the company has received the prestigious international ISO 13485 certification for its quality system for design, development, production and sales of medical devices. The company...

Realtime Achieves ISO 13485:2003 Certification Targeting BioTech Quality Initiative

PLANO, Texas, June 12 /PRNewswire/ -- The Realtime Group ( http://www.TheRealtimeGroup.com ) announced today that it has received ISO 13485:2003 certification for its Quality Management System; the full scope covers design, prototyping, and testing services in Software Engineering, Embedded Mi...

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iso in Biological Products

4',6-diamidino-2-phenylindole, dihydrochloride (DAPI) *FluoroPure™ grade* from Molecular Probes (Invitrogen)

Description:... Because it is manufactured at our iso 9001–certified facilities in Eugene, Oregon, we can guarantee that FluoroPure Grade DAPI is greater than or equal to 98% pure by HPLC....
Company:Molecular Probes (Invitrogen)

propidium iodide *FluoroPure™ grade* from Molecular Probes (Invitrogen)

Description:... Because it is manufactured at our iso 9001–certified facilities in Eugene, Oregon, we can guarantee that FluoroPure grade propidium iodide is greater than or equal to 98% pure by HP...
Company:Molecular Probes (Invitrogen)

Polaroid B&W positive, 3 x 4 inch pack film, 20 exp from Hoefer, Inc.

Description:... Polaroid black & white positive, 3 x 4 inch pack film, iso 3000/ 36 ASA DIN (20 expsures). For use in the Polaroid Direct Copy Camera (PHC34)....
Company:Hoefer, Inc.

Microsart e.motion Membrane Filters from Sartorius AG

Description:...rs. Outstanding recovery rates for microorganisms 0.45 m are acc. to iso 7704 Multi-fit: Fits into other dispensers Protective paper-free ...mbrane filter lot these membranes are also tested and released according to iso 7704...
Company:Sartorius AG

Microsart e.motion Membrane Filters from Sartorius AG

Description:... sealed band guarantees uniform dispensing of the individual membrane filters. Outstanding recovery rates for microorganisms 0.45 m are acc. to iso 7704 Multi-fit: Fits into other dispensers Protective paper-free Packaged on a special pleated band Product data are printed on Hi...
Company:Sartorius AG

miVacDNA Concentrator from GeneVac, Inc.

Description:...on. Very easy to use simple, clear user interface. Low cost of ownership. Well built and quiet operation. Manufactured in the UK under iso 9001 standard. ...
Company:GeneVac, Inc.

miVac Duo Concentrator from GeneVac, Inc.

Description:...on. Very easy to use simple, clear user interface. Low cost of ownership. Well built and quiet operation. Manufactured in the UK under iso 9001 standard. ...
Company:GeneVac, Inc.

Thermo Scientific IEC Centra-CL5R from Thermo Scientific

Description:...y Time Thermo IEC centrifuges are outfitted with the most advanced safety features available. The Centra-CL5R is CE marked, manufactured under the iso 9001 quality system, and meets IEC 1010-2-020 international standards for mechanical containment. An automatically locking lid will not open until t...
Company:Thermo Scientific

Endotoxin Testing from AbD Serotec

Description:... • Receive royalties for your hard work and endeavour! Bring us your idea and let us build it up and market it internationally. We work under iso 9001 quality assurance in design, development, production, installation and servicing. • Reliable reproducibility of your experiments require...
Company:AbD Serotec

Hybridoma Storage from AbD Serotec

Description:... • Receive royalties for your hard work and endeavour! Bring us your idea and let us build it up and market it internationally. We work under iso 9001 quality assurance in design, development, production, installation and servicing. • Reliable reproducibility of your experiments require...
Company:AbD Serotec

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