为ISO 13485认证选择合适的代理商

ISO 13485 certification for medical devices is an excellent quality management system required for regulatory functions which is an ISO standard, it represents the necessities for a complete best control machine for the design and production of medical devices. Regulatory necessities are more and more stringent during every step of a product’s lifecycle, along with services and delivery. Increasingly, more agencies within the industry are expected to illustrate their QMS procedures.

国际标准组织将很少的标准设定为在组织中实施QM的要求。医疗设备行业中有超过数千个ISO标准。

如果我们专门谈论ISO 13485，它将实施由参与医疗设备设计，生产，安装和维修的组织。它可以帮助制造商进行审核流程,but there is some ambiguity among the industry and stakeholder about who can certify for ISO 13485which is a requirement for the registration of the devices under the MDR, 2017 by CDSCO.

MDR, 2017 uses the concept of Notified body (NBs) as practice in EU for the audits under MDR of class A and Class B medical devices. As aISO 13485 medical device consultant我们知道NB，CB和其他监管机构之间的区别，并且我们相应地协助客户。

• ISO 13485认证：

Medical device manufacturers who wish to sell their device in EU market need to have a relationship with the Notified bodies as these are the bodies whose role is to perform conformity assessment of new medical device .Offenly these are private firms with the experts from the field of risk management & medical device safety and standards. NBs are the registered under rule 13 as a body who carry out audit of manufacturing site, assessment and verification of specified category to establish conformity assessment with standards.它没有提及任何地方ISO 13485或认证词。

ISO 13485 was introduced as a certificate of compliance由NABCB认可(National Accreditation Board for Certification Bodies) or IAF in respect of medical devices.

这清楚地表明ISO 13485通过经过认证的身体i.e CB not from NB (Notified Body).

CB should be accredited by NABCB，印度国家认证机构（AB）。CBS列表可在NABCB链接上找到：

https://nabcb.qci.org.in/about.php

Countries like US and Japan have multiple Accreditation body (AB) whereas some countries have single national AB. ISO 13485 certification operates under the oversight of IAF through Abs in each country .IAF define 7 technical areas in a document IAFMD which is free to download from their website. So, the bottom line is industry make sure that the Certified body (CB) is accredited by an AB. The ISO 13485 should carry the logo of AB which will ensure that it is accredited for the scope under which your industry falls.

值得注意的是，市场上有数量的非IAF CBS提供ISO 13485证书。要从正确的CB获得此证书，您应该聘请有监管领域经验的合适顾问。

To summarize, few point to remember

• ISO 13485证书将从不从NB的CB获得。

• The certificate should be from CB accredited by NABCB or any IAF member AB which seems to be present in INDIA.
• The certificate should carry logo of the AB.