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substance, mixture of substances, material, apparatus or instrument (including the computer program necessary for its proper use or application), used alone or in combination in the diagnosis, monitoring or prevention of human or auxiliary diseases in the treatment of the same and of the disability, as well as the employees in the replacement, correction, restoration or modification of the anatomy or human physiological processes. Medical devices include products of the following categories: medical equipment, prostheses, orthotics, functional aids, diagnostic agents, supplies for dental use, surgical, healing and hygiene products. ISO 13485:2016 Certificates meets the requirement of IEC 60601-2-25 : 1993 + A1: 1999 safety of
Electrocardiograms.
131:
93/42/EEC, 90/385/EEC, and 98/79/EEC before allowing their sale. A fundamental aspect of proving conformity lies in the establishment and implementation of a
Quality Management System compliant with ISO 9001, ISO 13485, and ISO 14971. While it's important to note that the European Union Directives don't explicitly mandate certification to ISO 9001 and/or ISO 13485, it is the preferred approach for demonstrating compliance to these standards, and this certification is issued by specialized organizations referred to as "Registrars."
158:(IMDRF) and is structured differently from the GHTF as only the regulators, that are primary members of the group, get to make many of the decisions. The IMDRF main membership (the regulators) do want to have non-regulators involved without voting rights and in this way they are hoping to get the process and documents completed quicker than under the GHTF system (regulators & non-regulators were equal in voting rights) that worked reasonably well, but somewhat slow.
135:
the CE mark and the authorization to market the medical device within the
European Union. It's important to underline that the Notified Body's assessment scrutinizes the company's Quality Management System in great detail, along with a meticulous review of the requisite Technical Documentation. This comprehensive evaluation is a crucial element that the Notified Body takes into account when granting the certificate of conformity for the company's product or products.
2812:
168:(NOM) to control manufacture of medical devices inside the country. NOM-241-SSA1-2012, Buenas Practicas de FabricaciĂłn para Establecimientos dedicados a la FabricaciĂłn de Dispositivos MĂ©dicos. The scope of application is mandatory in the national territory, for all establishments dedicated to the process of medical devices marketed in the country. The
138:
In summary, the journey to compliance with
European regulatory requirements for medical devices entails a multi-faceted approach, with ISO 13485 serving as a cornerstone and the involvement of Notified Bodies as a key step to gain the necessary certifications and permissions for market access in the
176:
In 2017, The
Farmacopea de los Estados Unidos Mexicanos (United Mexican States Pharmacopoeia), medical industrial sectors and Cofepris are working together for updating NOM-241 Standard, putting special attention on managing risks during manufacture and regulating by manufacturing lines some of the
134:
Furthermore, some of these registrars also serve as
Notified Bodies, which play a pivotal role in the pre-market assessment of certain medical devices. When a Notified Body conducts a thorough evaluation and issues a positive assessment, it results in the coveted certificate of conformity, granting
130:
Compliance with ISO 13485 is often viewed as the initial step in ensuring adherence to
European regulatory requirements. This is particularly significant when it comes to assessing the conformity of Medical Devices and In-vitro Diagnostic Medical Devices in accordance with European Union Directives
180:
In Spain, medical devices are named in ISO-13485 as "Sanitary
Products" as Castellano-language translation of ISO-13485, but in Mexico they are known as "Medical Devices" and correspond to those used in medical practice and that meet the definition established by NOM-241 as: Medical device, to the
48:
Though it is tailored to the industry's quality system expectations and regulatory requirements, an organization does not need to be actively manufacturing medical devices or their components to seek certification to this standard, in contrast to the automotive sector's
88:
the promotion and awareness of regulatory requirements as a management responsibility. Examples of market-specific regulatory requirements include 21 CFR 820, the
Quality System Regulation for medical devices sold in the United States, enforced by the U.S.
172:
is the body assigned to its control, verification and to grant the records of compliance to the companies that implement this
Standard of Good Manufacturing Practices. This standard is partially in line with ISO 13485: 2003 and ISO 9001: 2008.
2138:
153:
Guidelines" (GHTF). The GHTF guidelines are slowly becoming universal standards for design, manufacture, export and sales of various medical devices. The GHTF has been replaced in the last few years by the
277:
37:. The latest version of this standard supersedes earlier documents such as EN 46001 (1993 and 1996) and EN 46002 (1996), the previously published ISO 13485 (1996 and 2003), and ISO 13488 (also 1996).
339:
471:
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77:, whereas ISO 13485 requires only that the certified organization demonstrate the quality system is effectively implemented and maintained. Additionally, the ISO 9001 requirements regarding
177:
most important medical devices manufacturing processes. This standard will be published in August 2018, and 180 days after publication it will become mandatory for the industry.
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EN ISO 13485 is published by CEN, creating a European Norm version of the international standard, and the previous European standard (EN 46001) is withdrawn.
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EN ISO 13485 is revised so that it harmonizes with the three European directives associated with the medical sector: 93/42/EEC (medical devices), 98/79/EC (
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444:"NORMA Oficial Mexicana NOM-241-SSA1-2012, Buenas prácticas de fabricación para establecimientos dedicados a la fabricación de dispositivos médicos"
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372:"Summary list of titles and references of harmonised standards related to medical devices - DG Enterprise & Industry. European Commission"
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This standard adopted by CEN as EN ISO 13485:2012 is harmonized with respect to the European Medical Devices Directive 93/42/EEC.
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This standard adopted by CEN as EN ISO 13485:2003/AC:2007 is harmonized with respect to the European medical device directives
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ISO 13485 is now considered to be inline standard and requirement for medical devices even with "
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specific requirements for documentation and validation of processes for sterile medical devices
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Quality systems – Medical devices – Particular requirements for the application of EN ISO 9001
73:. A principal difference, however, is that ISO 9001 requires the organization to demonstrate
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Medical devices -- Quality management systems -- Requirements for regulatory purposes
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diagnostic medical devices), and 90/385/EEC (active implantable medical devices).
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Overview, guidance and regulatory compliance for EU medical device manufacturers
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While it remains a stand-alone document, ISO 13485 is generally harmonized with
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specific requirements for inspection and traceability for implantable devices
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ISO 13485 Standard: Medical devices — Quality management systems
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List of International Organization for Standardization standards
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Mexico published on October 11, 2012, a national standard as a
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specific requirements for verification of the effectiveness of
29:(ISO) for the first time in 1996, and contains a comprehensive
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426:"CENELEC - Standards Development - List of Technical Bodies -"
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The current ISO 13485 edition was published on 1 March 2016.
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93/42/EEC, required for doing business in the European Union
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controls in the work environment to ensure product safety
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CFR - Code of Federal Regulations Title 21, Part 821
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www.iso.org/foreword-supplementary-information.html
211:(CEN), forming the basis for developing ISO 13485.
126:specific requirements for cleanliness of products
61:supply chain manufacturer can seek registration.
408:"International Medical Device Regulators Forum"
27:International Organization for Standardization
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156:International Medical Device Regulators Forum
81:are absent from the medical device standard.
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298:"FOREWORD - SUPPLEMENTARY INFORMATION"
209:European Committee for Standardization
25:is a voluntary standard, published by
111:activities during product development
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84:Other specific differences include:
59:International Automotive Task Force
53:, where only firms with an active
33:for the design and manufacture of
14:
122:corrective and preventive actions
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390:"GHTF is no longer in operation"
151:Global Harmonization Task Force
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494:'s Quality System Regulation
492:Food and Drug Administration
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91:Food and Drug Administration
57:, or on the bid list, of an
273:Good manufacturing practice
146:, 90/385/EEC and 98/79/EC.
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358:"Understanding ISO 13485"
255:ISO 13485 (3rd Edition).
235:ISO 13485 (2nd Edition).
219:ISO 13485 (1st Edition).
95:Medical Devices Directive
31:quality management system
166:Norma Oficial Mexicana
79:customer satisfaction
75:continual improvement
55:request for quotation
207:is published by the
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533:by standard number
472:Guide to ISO 13485
344:www.bsiamerica.com
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479:: ISO Website
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412:www.imdrf.org
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2669:27000 series
1914:
451:. Retrieved
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429:
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411:
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394:www.ghtf.org
393:
384:
376:the original
366:
352:
343:
334:
323:. Retrieved
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195:Description
179:
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148:
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137:
133:
129:
83:
68:
51:ISO/TS 16949
47:
39:
22:
19:
18:
16:ISO standard
2457:20000–29999
1609:10000–19999
320:www.iso.org
2831:Categories
2236:16949 (TS)
1833:11941 (TR)
531:standards
453:19 October
325:2016-03-24
284:References
185:Chronology
44:Background
2191:15926 WIP
1555:9592/9593
1480:9000/9001
1368:8805/8806
268:ISO 14971
203:EN 46001
144:93/42/EEC
103:focus on
20:ISO 13485
2816:Category
541:List of
262:See also
245:in vitro
170:Cofepris
71:ISO 9001
2717:29199-2
2589:23094-2
2584:23094-1
2574:23090-3
2443:19794-5
2438:19775-1
2226:16612-2
2216:16355-1
1905:13406-2
1863:12234-2
1631:10118-3
2731:30000+
1570:9797-1
1378:8820-5
1323:8501-1
879:1073-2
874:1073-1
558:1–9999
2798:80000
2793:56000
2788:55000
2783:50001
2778:45001
2773:42010
2768:40500
2763:39075
2758:38500
2753:37001
2748:32000
2743:31000
2738:30170
2722:29500
2712:29148
2708:29110
2704:28000
2699:27729
2694:27006
2689:27005
2684:27002
2679:27001
2674:27000
2664:26324
2659:26300
2654:26262
2649:26000
2644:25964
2639:25178
2634:24728
2629:24707
2624:24617
2619:24613
2614:24517
2609:23941
2604:23360
2599:23271
2594:23270
2579:23092
2569:23009
2564:23008
2559:23003
2554:23000
2549:22537
2544:22395
2539:22301
2534:22300
2529:22275
2524:22000
2519:21827
2514:21500
2509:21122
2504:21047
2499:21001
2494:21000
2489:20830
2484:20802
2479:20400
2474:20121
2469:20022
2464:20000
2448:19831
2433:19770
2428:19757
2423:19752
2418:19600
2413:19510
2408:19509
2403:19508
2398:19507
2393:19506
2388:19505
2383:19503
2378:19502
2373:19501
2368:19500
2363:19439
2358:19407
2353:19136
2348:19125
2343:19115
2338:19114
2321:19092
2316:19011
2311:19005
2306:18916
2301:18629
2296:18245
2291:18181
2286:18014
2281:18004
2276:17799
2271:17506
2266:17442
2261:17369
2256:17203
2251:17100
2246:17025
2241:17024
2231:16750
2221:16485
2211:16262
2206:16023
2201:15938
2196:15930
2186:15926
2181:15924
2176:15919
2171:15897
2166:15707
2154:15706
2149:15693
2144:15686
2139:15511
2134:15504
2129:15438
2124:15445
2107:15444
2102:15408
2097:15398
2092:15291
2087:15288
2082:15189
2077:15022
2072:14971
2067:14882
2062:14764
2057:14698
2052:14651
2047:14649
2042:14644
2037:14617
1985:14496
1980:14443
1975:14396
1970:14289
1965:14224
1960:14031
1955:14000
1950:13818
1945:13816
1940:13616
1935:13584
1930:13568
1925:13567
1920:13490
1915:13485
1910:13450
1900:13399
1895:13250
1890:13216
1873:13211
1868:12620
1858:12207
1853:12182
1848:12052
1843:12006
1838:11992
1828:11941
1818:11940
1813:11898
1808:11889
1803:11801
1798:11785
1793:11784
1788:11783
1783:11544
1778:11404
1773:11179
1768:11172
1763:11170
1758:11073
1753:10967
1748:10962
1743:10957
1738:10861
1733:10746
1728:10664
1723:10646
1718:10628
1713:10589
1708:10585
1703:10383
1671:10303
1666:10279
1661:10218
1656:10206
1651:10179
1646:10165
1641:10161
1636:10160
1626:10116
1621:10007
1616:10006
192:Year
1696:-238
1600:9995
1595:9985
1590:9984
1585:9945
1580:9899
1575:9897
1565:9660
1560:9594
1550:9564
1545:9529
1540:9506
1535:9496
1530:9407
1525:9362
1520:9314
1515:9293
1510:9241
1505:9227
1500:9141
1495:9126
1490:9075
1485:9036
1475:8879
1428:-8-I
1383:8859
1373:8807
1363:8691
1358:8652
1353:8651
1348:8632
1343:8613
1338:8601
1333:8583
1328:8571
1318:8373
1313:8217
1308:8178
1303:8093
1298:8000
1293:7942
1288:7816
1283:7813
1278:7812
1273:7811
1268:7810
1263:7736
1258:7637
1246:7498
1241:7200
1236:7185
1231:7098
1226:7064
1221:7027
1216:7010
1211:7002
1206:7001
1201:6943
1196:6709
1191:6523
1186:6438
1181:6429
1176:6425
1171:6385
1166:6373
1161:6346
1156:6344
1151:6166
1146:5964
1141:5807
1136:5800
1131:5776
1126:5775
1121:5725
1116:5428
1111:5427
1106:5426
1101:5218
1096:4909
1091:4217
1086:4165
1081:4157
1076:4031
1071:3977
1066:3950
1061:3901
1056:3864
1051:3602
1046:3601
1041:3307
1036:3297
1014:3166
1009:3103
1004:3029
999:2921
994:2852
989:2848
984:2788
979:2720
974:2711
969:2709
964:2533
959:2281
954:2240
949:2146
944:2145
939:2108
934:2047
929:2033
924:2022
919:2015
914:2014
909:1989
904:1745
899:1629
894:1538
889:1413
884:1155
869:1007
864:1004
859:1000
682:68-1
455:2017
252:2016
240:2012
232:2003
224:2000
216:1996
200:1993
2030:-20
2025:-17
2020:-14
2015:-12
2010:-11
2005:-10
1691:-28
1686:-22
1681:-21
1676:-11
1468:-16
1463:-15
1458:-14
1453:-13
1448:-12
1443:-11
1438:-10
854:999
849:965
844:898
839:860
834:843
829:838
824:764
819:732
814:704
809:690
804:668
799:657
794:646
762:639
757:519
752:518
747:500
742:361
737:306
732:302
727:262
722:261
717:259
712:233
707:228
702:226
697:217
692:216
687:128
675:-13
670:-12
665:-11
660:-10
529:ISO
2833::
2331:-2
2326:-1
2159:-2
2117:-9
2112:-3
2000:-6
1995:-3
1990:-2
1883:-2
1878:-1
1822:-2
1433:-9
1423:-8
1418:-7
1413:-6
1408:-5
1403:-4
1398:-3
1393:-2
1388:-1
1251:-1
1029:-3
1024:-2
1019:-1
787:-6
782:-5
777:-3
772:-2
767:-1
655:-9
650:-8
645:-7
640:-6
635:-5
630:-4
625:-3
620:-1
615:-0
610:31
605:17
600:16
549:–
545:–
490:,
446:.
428:.
410:.
392:.
342:.
318:.
300:.
1824:)
1820:(
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575:3
570:2
565:1
521:e
514:t
507:v
457:.
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304:.
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