Certificate
of Registration of Quality System to l.S. EN ISO
13485 ...
l.S. EN ISO 13485:2003. The National Siandards Auihi>rit; >>l' Ireland certifies that ... has hem assessed an.i deemed u> oimph w nil the pn>\ ¡sums iiflhe ...
http://www.lightguides.com/pdf/I-S-EN-ISO-13485-2003.pdf
ISO 9001:2008 ISO 13485:2003 ISO
14001:2004 BS OHSAS 18001:2007
Manual. ISO 9001:2008. ISO 13485:2003. ISO 14001:2004. BS OHSAS 18001:2007. Third edition ...... part numbers (PN). The company had approximately 250 ...
http://www.quality-works.com/download/the-perfect-manual.pdf
1 WYKAZ POLSKICH
NORM (PN) WPROWADZAJĄCYCH EUROPEJSKIE NORMY
...
PN-EN ISO 13485:2005. Wyroby medyczne - Systemy zarządzania jakością -. Wymagania do celów przepisów prawnych. 37. EN ISO 13485:2003. EN ISO 13488:2000 ...
http://www.normalizacja.pl/pdf/D90_385.pdf
1 Polska Norma
zharmonizowana WdroŜona norma europejska Lp. Numer ...
EN ISO 13485:2003. EN ISO 13485:2000. EN ISO 13488:2000. 31.07.2006. 239. PN-EN ISO 13488:2002. Systemy jakości - Wyroby medyczne - ...
http://www.normalizacja.pl/pdf/D93_42.pdf
NIDHI-1
ENDOSCOP PDF.cdr
All these accessories are manufactured as per ISO 13485-2003 and CE 1023 standards. .... NMS-PCN-9-PN. 12 FR x 360mm (Peanut Jaw). NMS-PCN-12-PN ...
http://nidhimeditech.com/download-catalogue/endoscopic.pdf
12.
Global Requirements for Medical Applications of Chitin and its
...
described in PN-EN ISO 10993-1:20041 and PN-EN 14630:20052 Standards), pro- .... ISO 13485:2003 'Medical devices - Quality management systems - Requirements ...
http://www.ptchit.lodz.pl/pliki/PTChit_(x8nm44j2o4pb8ytj).pdf
CONCORDE
HOTEL SHAH ALAM, SELANGOR 23 NOVEMBER 2009 REGISTRATION FORM
Pn Hamizah Yaakub/ En Arifuddin Abdullah/ Cik Yusfahliza Mohd Yusof/ Pn.HammidahYahaya ... REQUIREMENTS FOR REGULATORY PURPOSES (ISO 13485:2003, IDT) ...
http://www.ammi.com.my/pdf_2009/Brochure medical device.pdf
19 September 2008
MEETING THE REQUIREMENTS OF ISO 13485:2003 BY CONTRACT OR COMPONENT ... Northern Corridor Implementation Authority (attn: Ms. Yin-Wai, Choy, Pn. Noorrul ...
http://www.ammi.com.my/pdf_2008/Agenda & reply slip_081125_NCIA.pdf
POLSKIE CENTRUM AKREDYTACJI
PROGRAM AKREDYTACJI JEDNOSTEK ...
8 Sty 2008 ... the application of ISO 13485:2003;. PN-EN ISO 14971:2004 Wyroby medyczne. Zastosowanie zarządzania ryzykiem do wyrobów medycznych; ...
http://www.pca.gov.pl/doc/DAC-15.pdf
FMM
Institute
and ISO 13485:2003 Internal Quality Auditor, he is also a Quality Management Consultant ... Ms Ravathi/Pn Hafifah. FMM Institute. Tel: 03-62867200 ...
http://www.fmm.edu.my/SharedImages/Library/pdf/F_1569.pdf
Contents
Contact Person: Pn Haslinda Harun. Negeri Sembilan Branch ...... Apply the ISO 13485:2003 QMS to provide safe and effective products. ...
http://www.fmm.edu.my/SharedImages/Library/pdf/F_1733.pdf
Quality
Management systems - Process Validation Guidance
validation requirements found in clause 7.5.2 of ISO 13485:2003. ...... seals will be completed for pouches PN 96-122 and PN 88-010. ...
http://www.ghtf.org/documents/sg3/sg3_fd_n99-10_edition2.pdf
CARBON
DIOXIDE DETECTOR When Your Care is Critical
CO2 Easy is a trademark and Bag Easy is a registered trademark of Westmed, Inc. й 2006 Westmed, Inc. All rights reserved. PN 74558/Rev. 02. ISO 13485:2003 ...
http://westmedinc.com/linesheets/CO2 Easy Rev.03.pdf
The New
Definition of Accuracy
ISO 13485:2003. Authorized Representative in the E.U.. MT Promedt Consulting GmbH ... When Your Care is Critical. All rights reserved. PN 74514/Rev. 03 ...
http://westmedinc.com/linesheets/Mosquito Rev.03.pdf
1 WYKAZ POLSKICH NORM
ZHARMONIZOWANYCH Z DYREKTYWĄ 98/79/WE
EN ISO 10993-15:2009. Pierwsza publikacja. 26. PN-EN ISO 13485:2005. EN ISO 13485:2003. 2.04.2004. EN ISO 13488: 2000. EN ISO 13485: ...
http://www.pkn.pl/N_Zharm/98_79_WE.pdf
1 WYKAZ POLSKICH
NORM ZHARMONIZOWANYCH Z DYREKTYWĄ 90/385/EWG
PN-EN ISO 13485:2005. Wyroby medyczne -- Systemy zarządzania jakością --. Wymagania dla celów przepisów prawnych. EN ISO 13485:2003. 2.04.2004. EN ISO 13485 ...
http://www.pkn.pl/N_Zharm/90_385_EWG.pdf
第1 頁,共8 頁July
06
BS EN ISO 13485 2003. International standards and specifications / ..... PN 1997 .W37 2005. DVD. War of the worlds. 第5 頁,共8 頁. July 06 ...
http://cwintra.vtc.edu.hk/LIB/NBL0607.pdf
Layout 1
ISO 9001:2000 ISO 13485:2003. Puritan Medical Products Company LLC ... 3306-PN. Plastic shaft. 6” x 215”. 10/100. 3 lbs. 3316-PN. Plastic shaft. 6” x .141” ...
http://www.puritanmedproducts.com/Library/downloads/Polyester_Tipped.pdf
KURS AUDITOR WEWNĘTRZNY SYSTEMU ZARZĄDZANIA JAKOŚCIĄ WG NORMY
ISO ...
Przypomnienie wymagań dla auditorów wewnętrznych wg PN-EN ISO. 19011:2004. 5. Szczególne wymagania EN ISO 13485:2003 – a) przegląd wymagań b) interpretacja, ...
http://www.speed.stargard.pl/panel/realizacje/docs/1212493f7590ec86bprogram i cel kursu 13485.pdf
EXCEL
PTCA Accessory Kits
'Available w/salmon torque device PN: AK0083. AK1120. Excel PTCA Accessory Kit, ... EXCELS» AS. ISO 13485:2003. Ph. 810-714-4775. Fx. 810-714-4059.
http://www.excelmedicalproducts.com/images/PDF/access.pdf
Line Card Brochure Back Final.jpg
*Available w/salmon torque device PN: AK0083 ... MEDICAL .PRODUCTS. ISO 13485:2003. 3145 Copper Ave. Fenton, MI 48430. Ph. 810-714-4775. Fx. 810-714-4059.
http://www.excelmedicalproducts.com/images/PDF/AccessoryKitCard.pdf
Międzynarodowe normy ISO serii 9000
ISO 13485:2003. ISO/TR. 14969:2004. Systemy zarządzania jakością. Szczegółowe wymagania do stosowania ISO 9001:2000 w przemyśle motoryzacyjnym. PN ISO/TS ...
http://www.ioz.pwr.wroc.pl/pracownicy/z_zymonik/Pliki/Wykład Zarzadzanie jakością/(Microsoft PowerPoint - Mi_352dzynarodowe normy ISO serii 9000 i zasady systemowego zarz_271dzania jako_234ci_271 _(aktualny_)).pdf
13 No - SIRIM
Berhad - The leading organisation in industrial ...
Pn. Zurina Mohd Bistari. Tel: 603-5544 6235. E-mail: zurina@sirim.my ..... ISO 13485:2003 standard is a main issue in this new regulation. ...
http://www.sirim.my/f_corp/services.pdf
HEALTHCARE SERVICES
by Pn Norlia Musa, Senior Consultant .... requirements of ISO 13485:2003 Medical ... What is ISO 13485:2003? ISO 13485:2003 is a sector specific ...
http://www.sirim.my/f_corp/jan05.pdf
IB_11-2008
[PL_4].qxd
W artykule porównano normę medyczną ISO 13485:2003 z nor- mą zintegrowanego systemu zarządzania ... oznaczona symbolem PN-EN ISO 13485 „Wyroby medyczne. ...
http://www.zahir.pl/abstracty/00000151.pdf
SIERRA
plus
60601-1; ISO 9001:2000; ISO 13485:2003. Specifications are subject to change without notice ... parent. VIDAR Publication PN 15788-001, Rev H, April 2008.
http://ims.es/pdf/esp/sanidad/vidar/EN_Sierra-Vidar.pdf
PROFILING LEUKEMIA
PRODUCT REFERENCE. TARGET. DESCRIPTION. 5. PN. DESCRIPTION. PRODUCT REFERENCE. REFERENCE NAME .... FACILITIES & QMS COMPLIANT WITH ISO 13485:2003 STANDARD ...
http://www.ipsogen.com/fileadmin/documents/Leucemie/Ipsogen_Leukemia_ProductList2010.pdf
The Medical Device and Instrumentation Industry
Vigilenz attained its ISO 13485 : 2003 (by TUV Product Services, Germany) accreditation in February 2004 .... Pn. Rohana at 04-228 3306. No. Publications ...
http://www2.seri.com.my/Economic Briefing - Pg Econ Rept/EconBrief2006-02.pdf
zaktualizowany
wykaz norm urządzenia diagnostyczne in vitro
PN-EN ISO. 13485:2005. Wyroby medyczne. Systemy zarządzania jakością. Wymagania dla celów przepisów prawnych. EN ISO. 13485:2003. PN-EN ISO. 13485:2004 (U) ...
http://www.pie.olsztyn.pl/serwis/wyroby/20/wykaznz.pdf
zaktualizowany
wykaz norm aktywne implanty medyczne
PN-EN ISO. 13485:2005/AC:2007. Wyroby medyczne -- Systemy zarządzania jakością -- Wymagania dla celów przepisów prawnych. EN ISO. 13485:2003/AC: ...
http://www.pie.olsztyn.pl/serwis/wyroby/9/wykaznz.pdf
X-Ray Film
Digitizer for Mammography Priors, Digitized Film CAD
9001:2000; ISO 13485:2003. Specifications are subject to change without notice. 365 Herndon Parkway ... VIDAR Publication PN 15790-001 Rev I, April 2008.
http://websheets.net/library/pdf2/VIDARcadpro.pdf
X-Ray Film
Digitizer for Film Dosimetry and IMRT
IEC 60601-1; IEC 60950; ISO 9001:2000; ISO 13485:2003. Specifications are subject to change without ... VIDAR Publication PN 15786-001, Rev E, January 2006.
http://websheets.net/library/pdf/vidar-dosi.pdf
vidar
Sierra
IEC 60601-1; ISO 9001:2000; ISO 13485:2003. Specifications are subject to change without notice. ... VIDAR Publication PN 15788-001, Rev D, January 2006 ...
http://www.cynaptix.com/Downloads/Vidar_Sierra_Plus.pdf
For
PACS & Remote Primary Diagnosis
IEC 60601-1; IEC 60950; ISO 9001:2000; ISO 13485:2003 ... VIDAR Publication PN 15787-001, Rev E, January 2006. D A T A S H E E T ...
http://www.cynaptix.com/Downloads/Vidar_Diagnostic_Pro.pdf
For PACS
& Remote Primary Diagnosis
IEC 60601-1; IEC 60950; ISO 9001:2000; ISO 13485:2003. Specifications are subject to change without ... VIDAR Publication PN 15787-001, Rev E, January 2006.
http://www.esids.co.kr/down/diagnosticprodatasheet.pdf
X-Ray Film
Digitizer for Mammography CAD
IEC 60601-1; IEC 60950; ISO 9001:2000; ISO 13485:2003. Specifications are subject to change ... companies. VIDAR Publication PN 15790-001 Rev D, January 2006.
http://www.esids.co.kr/down/cadprodatasheet.pdf
KoKo®
Trek
FDA QSR, ISO 13485:2003, MDD 93/42/EEC, EN 60601-1,. 60601-1-1, 60601-1-2, 60601-1-4, CMDCAS/ Health Canada ... PN 633051 rev A. References: ...
http://www.carestream.com/uploads/file/nspire-kokotrek.pdf
Mosquito Brochure-F2
ISO 13485:2003. Authorized Representative in the E.U. ... PN 74514/Rev. 01. crickettTM. NEEDLE PROTECTION SYSTEM. The New. Definition of Accuracy ...
http://www.carestream.com/uploads/file/Westmed-Mosquito Brochure.pdf
KoKo®
Legend
FDA QSR, ISO 13485:2003, MDD 93/42/EEC, EN 60601-1,. 60601-1-1, 60601-1-2, ... Standardisation of spirometry, Eur Respir J 2005; 26: 319-338. PN 633048 rev A.
http://bayviewmedical.com/pdf/KoKoLegend.pdf
KoKo® PFT
Spirometer
FDA QSR, ISO 13485:2003, MDD 93/42/EEC, EN 60601-1,. 60601-1-1, 60601-1-2, 60601-1-4, ... Merlin and GATE are trademarks of nSpire Health. PN 633049 rev A.
http://bayviewmedical.com/pdf/KoKoPFT.pdf
Software Validation Pack
Upgrade Manual (PN A66590). See www.ceLeader.com for more information ... ISO 13485: 2003 Certified Quality Management System registration number MD 19.0062 ...
http://www.beckmancoulter.com/literature/Bioresearch/A79486AA.pdf
Prospekt 1 Behandl_Liegen_engl.qxd
ISO 13485:2003 and direction. 93/42/EWG attachment VI. .... Pro-Line PN. Heavy-duty examination and treatment couch. Frame made of two ...
http://www.beka-hospitec.de/pdf/Prosp_1_Behandlungsliegen_engl.pdf
Prospekt
#1 2006 Englisch.cdr
according to DIN EN ISO 9001:2000, ISO 13485:2003 and direction .... Pro-Line Treatment table PN. Head part positive and negative adjustable via 2-clamp ...
http://www.beka-hospitec.de/pdf/Produktverzeichnis_1_engl.pdf
Planar's
StereoMirror Technology Versus Red Rover/True 3Di
bool.html&r=1&f=G&l=50&d=PALL&RefSrch=yes&Query=PN%2F6703988 for details. .... Planar has also obtained ISO 13485:2003 registration for medical products. ...
http://www.planar3d.com/pdf/StereoMirror_v_RedRover.pdf
VIRO-IMMUN at
a glance
ISO 9001:2008 and EN ISO 13485:2003/AC:2007. •. Product focus: ... IgM/Chlamydia pn.) incubations times: 30min sample / 30min conjugate / 10min ...
http://www.viro-immun.de/pdf/presentation.pdf
product range
we are a total of over 60 employees, we are ISO 13485:2003 certified and a great number ..... Legionella pn. IgA, cut-off *. Legionella pn. IgG, cut-off * ...
http://www.diagnostica.fi/fileadmin/user_upload/liitteet/Dialab_Katalogi.pdf
C:\Dokumente und Einstellungen\
Probe 3 PN is placed in the paren- chyma through a burr hole. Probe 3 ..... DIN EN ISO 13485:2003 certified. 0297. © by Spiegelberg (GmbH & Co.) KG, 2007 ...
http://www.spiegelberg.de/products/documents/ICP-ProspektEnglish.pdf
Mine
Safety and Health Administration (MSHA) - Comments on Public
...
Manufactured utilizing an ISO 13485:2003 compliant quality management system. •. System Specifications ... 6530-01-505-0526 PN 793035-001. INTRODUCTION ...
http://www.msha.gov/regs/comments/06-722/ab44-comm-02.pdf
POLICY OF THE
INTEGRATED MANAGEMENT SYSTEM
Safety PN-N 18001:2004 and Food Safety EN ISO 22000:2005 Management Systems and Quality of Medical Devices. System EN ISO 13485:2003 and 93/42/EEC. ...
http://www.aflofarm.pl/Polityka_Farmacja_en.pdf
When
Your Care is Critical
PN 74044/Rev. 05. ISO 13485:2003. Now your safety is just a click away. Designed to minimize the risk of needlestick injuries, the ...
http://mail.westmedinc.com/linesheets/ABG Pulset Rev. 06.pdf
1 2
