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ISO 13485 certificate & ISO 13485 consultants for ISO certification. ISO 13485 certificate consultants and training in Bangalore
What is ISO 13485: 2003 Medical devices -- Quality management systems?
ISO 13485 is a Management Systems Standard specifically developed for the manufacture of Medical Devices. Its primary objective is to facilitate harmonized medical device regulatory requirements. ISO 13485:2003 is the latest version of ISO 13485, published in July 2003. This standard is based on the ISO 9001:2000 process model approach.
ISO 13485 contains requirements that are essential for any organization operating at any tier in the medical device and pharmaceutical supply chain. It is especially relevant to manufacturers that wish to demonstrate applicable regulatory requirements, and by organizations whose services support medical device manufacturers.
Lakshy Management Consultant assisted dozens of companies around the World and in India also establishing and implementing effective ISO 13485 2003 Quality Management Systems. Lakshy Management Consultant provides services that help manufacturers understand what they need to do to place compliant devices on markets throughout the world.
Lakshy Consultancy has in-depth knowledge of the dynamic global market; we provide our consultation services &solutions as per the requirements of our clients. We provide a combination of real-world business value through technology and process solutions delivered with exceptional quality that help you manage your risk, strengthen your controls.
Our clients range from global fortune companies to smaller enterprises. We develop and help our clients implement a plan for exploiting...Read More
ISO-Bangalore consists of full-time trainers and consultants with a unique combination of manufacturing experience, business and financial...Read More
ISO Bangalore is a globally recognized ISO consulting and certification organization offering the highest quality services for a wide range...Read More