ISO 13485 is
an international management standard developed specifically for medical device
manufacturers. It provides a harmonized model for creating and maintaining an
effective quality management system (QMS) for the design and manufacture of
medical devices.
ISO 13485
Medical devices -- Quality management systems -- Requirements for regulatory
purposes is an International Organization for Standardization (ISO) standard
published for the first time in 1996; it represents the requirements for a
comprehensive quality management system for the design and manufacture of
medical devices. This standard supersedes earlier documents such as EN 46001
and EN 46002 (both 1997), the previously published ISO 13485 (1996 and 2003),
and ISO 13488 (also 1996). The current ISO 13485 edition was published on 1
March 2016.
Organizations
may use ISO 13485 standards during the entire development cycle of their
medical devices. The regulations assist companies during their product’s
initial conception, production, and post-production. These rules also cover
aspects such as distribution, installation, servicing, storage, and the
provision of associated services. The policies also outline the device’s final
decommissioning and disposal.
Companies can
use the ISO 13485 certification to help them build safer medical devices that
pass certification. Additionally, customers are more likely to trust the
quality of certified health tools.
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Certification Pvt. Ltd is one of the best ISO Certification Body for ISO 13485
in Lucknow (India). We are providing ISO certification in Lucknow at the best
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If you plan
to go for ISO 13485 Certification, you may ask for quotation by providing your
organization’s information in application form, you can download the inquiry
form available at the website or submit your inquiry through feedback.
Alternatively you may send your inquiry through mail to info@isoindia.org or
call us at: 0522-2756327-328, Mob: +91-9935002362.
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