ISO 13485 Certification in Delhi

The process of receiving certification under ISO 13485 requires an evaluation of all aspects of the company business processes and procedures to confirm conformity with the requirements outlined in the standard. Registration to these standards signifies that a manufacturer has implemented an integrative management system that complies with the applicable regulatory requirements for quality management. Those familiar with ISO 9001 will recognize that these sections align directly with those in that QMS standard. While ISO 13485 does share some similarities with ISO 9001, like using a process approach to meet requirements, it is not simply a duplicate effort. There are a number of important differences between ISO 9001 and ISO 13485. to additional Quality Management System (QMS) procedures and regulatory requirements before they will approve your device for sale.

Quality Management System EN ISO 13485 certifications 

Implementing and maintaining a robust quality management system (QMS) for your medical devices, products and services provides an indispensable foundation on which to build your business. EN ISO 13485 certification of your QMS demonstrates your commitment to operating at a global standard. 

The EN ISO 13485 certification process includes on-site audits to verify the capability and reliability of your quality management system. Our experts assess both the practical application and degree of effectiveness in the areas of design, development, production and customer care. 

As a well-respected and globally recognized Notified Body, we hold extensive accreditations and are able to serve you at regional facilities worldwide. Our one-stop-shop portfolio consists of comprehensive services designed to accommodate your unique circumstances and business needs. 

Optimize your QMS to the global standard of excellence! 

Four steps to EN ISO 13485 certification: 

Four steps to EN ISO 13485 certification-CDG  

Optional preliminary audit 

Voluntary site inspection and quality management documentation review assessing your readiness for full-scale Phase I & II auditing. 

Audit: Stage I 

Assessment of certification eligibility determined by results of on-site audit, quality management documentation analysis and business assessment. 

Audit: Stage II 

On-site evaluation of quality management system for excellence in areas of applied practice and efficiency. 

Certification 

Official confirmation certifying the integrity of your quality management system and complete compliance to the standards. 

First-time applicants benefit greatly from opting to undergo the preliminary audit. The process facilitates timely and effective preparation for the official EN ISO 13485 audit process. You are provided documented results that can be immediately applied for making adjustments in your processes prior to commencing with the mandatory audits. 

Transfer of Certification applications are also being accepted, in addition to applications for Certification Renewal. 

Our services are conducted using the four-eyes principle, which mandates the evaluations by the audit team and product experts be followed by an independent review for final decision. 

Choose an experienced partner for your certification-CDG 

We are a globally operational Notified Body with a wide range of accreditations and certified staff serving an extensive list of customers from every industry. Our EN ISO 13485 experts are here to serve you and your business around the world. Have confidence in your certification options and market access knowledge. Build your ideal certification package from a comprehensive list of services from a single provider.