Raomed S.A. the leading company in the design and manufacture of medical implants specific for each patient using 3D printing technology, received the quality certification "ISO 13.485:2016", the most recognized by regulatory bodies in the European Economic Community and other developed countries.
Córdoba, Argentina, July 1st, 2021
Raomed S.A. the leading company in the design and manufacture of medical implants specific for each patient using 3D printing technology, announced today that it has received the “ISO 13.485:2016” certification for custom-made medical devices and their management systems. This “ISO 13.485: 2016” certification indicates that Raomed’s quality management system meets the world’s most current medical device industry-specific regulatory requirements.
Santiago Olmedo, founder and President of the company, stated “We are very proud of this certification which demonstrates the commitment of our entire team to quality, and to meeting customer expectations, and reflects our rigorous approach to meeting specific international regulations. This certification represents an important milestone for our company in its plan to expand internationally and consolidate as one of the global leaders in the provision of 4.0 medical solutions.”
The “ISO 13485:2016” Standard (from the “International Organization for Standardization”) is a specific quality standard for the medical devices sector and is internationally recognized for quality systems that ensure that customer and regulatory requirements are consistently met throughout the life cycle of these medical devices. The “ISO 13.485 : 2016” is the most recognized quality system by the European Economic Community (EEC) authorities for products aspiring to be certified by its regulatory bodies.
Based in Córdoba (Argentina), Raomed S.A. has more than 10 years of experience in the design of patient specific implants and already has a significant number of cases successfully solved. Raomed provides its implants and bioengineering solutions to the most prestigious medical centers and hospitals in Argentina and Latin America, and in recent years its solutions are also being adopted by renowned medical centers in the developed world and Asia.