Iso 13485 Certification Services

ISO 13485 represents the requirements for a comprehensive management system for the design and manufacture of Medical Devices (Also called as MDQMS a Medical Devices Quality Management System)
The ISO 13485:2012 standard is the latest version of ISO 13485, published in March 2012. This standard is based on the ISO 9001 process model approach.
We are formally recognized under the regulatory systems of Europe and Canada and are committed to seeking formal recognition under the USA and Japanese regulatory systems as they evolve and the opportunities arise.
Whatever devices you produce, as a medical device manufacturer you have a responsibility to consistently deliver devices that are safe and effective. ISO 13485 is the international standard recognized for medical device regulations around the world.

Why ISO 13485 (MDQMS) Certification?

To achieve and to grant certification through the rigorous regulation through ISO 13485 helps your organization in fulfilling the specific requirements and expectations of managing medical devices. Medical devices, whether importer, distributor, producer or otherwise operating within the medical devices supply chain worldwide is a regulated sector. In addition, to help administer operations, processes, procedures and records and that equally provide objective evidence to customers and regulators on your commitment to consumers and quality of medical device and market acceptance.