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Iso 13485 2016 certification In Jaipur


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EC International Certifications is a professional certification and consulting firm offering Iso 13485 2016 Certification services in Jaipur. We provide 100% success guarantee for Iso 13485 2016 Certification in Jaipur. We are an Approved Service Provider with extensive knowledge and experience in all International Quality Assurance Standards. We will be happy to assist your company in the Iso 13485 2016 Certification process.

Iso 13485 2016 certification in Jaipur

Iso 13485 2016 certification In Jaipur is an internationally recognized quality standard which states the requirements of the Quality Management System (QMS) for the design and manufacture of Medical device directive in Jaipur. While it remains a stand-alone document, ISO 13485:2016 is based on ISO 9001:2008 with some additional clauses as well as the removal of some requirements. ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. The primary objective of ISO 13485:2016 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001. All requirements of Iso 13485 2016 certification in Jaipur & medical device directive certification in Jaipur & Management system certification are specific to organizations providing medical devices, regardless of the type or size of the organization.

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Iso 13485 2016 Certification In Jaipur

Iso 13485 2016 Certification In Jaipur