ISO 13485 Certification In Mumbai

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 and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations. ISO 13485 is a quality management standard for the manufacturers of medical devices. Obviously, medical device producers must be able to provide evidence that their devices consistently meet safety and quality standards as well as perform as intended for patients or consumers. ISO 13485 provides an international approach to meeting the wide-ranging requirements of medical device production and related services for the world market.

If applicable regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulatory requirements can provide alternative approaches that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity to ISO 13485:2016 reflect any exclusion of design and development controls. 

If any requirement in Clauses 6, 7 or 8 of ISO 13485:2016 is not applicable due to the activities undertaken by the organization or the nature of the medical device for which the quality management system is applied, the organization does not need to include such a requirement in its quality management system. 

COMPLIANCE & CERTIFICATION STEPS 

Preliminary Audit (Optional): During preliminary assessment, CDG reviews\ inspects your site to check documentation & implementation of quality management system for your organization, based on ICMED and ISO 13485 requirements. 

Phase 1 - Initial Certification Audit (Mandatory): CDG audits your site to determine that your organization is in compliance with the standard and ready for certification audits based on ISO 13485 and additional requirements of ICMED 13485. 

Phase 2 - Initial Certification Audit (Mandatory): Based on phase 1 outcomes, CDG does on-site certification audit to evaluate implementation and compliance of standard effectively and in a continuous manner. 

ICMED & ISO 13485 Certificate: Based on satisfactory phase 2 audit outcomes, CDG will issue a certificate confirming compliance with standards. 

BENEFITS 

ICMED 13485 and ICMED 9000 certification from CDG allows you to: 

Communicate high standards of your product quality in the medical device industry 

Gain a competitive edge with independent certification scheme 

Build a qualified team of local auditors & reviewers with global auditing experience, based on ISO 13485 standard