ISO 13485 Quality Management System Implementation Consulting. Health Products

13485 sistema gestion calidad dispositivo medico

About the ISO 13485 standard


ISO 13485 is an international standard that establishes requirements for quality management systems specifically designed for the medical device industry. It focuses on ensuring consistency in the design, development, production, installation and delivery of medical devices that are safe and fulfill their intended purpose.

The standard is critical for organizations seeking to demonstrate their ability to provide medical devices and related services that consistently meet both customer and regulatory requirements. ISO 13485 is widely recognized and accepted globally as a critical framework for medical device manufacturers and is often a requirement for operating in international markets.

It applies to all organizations involved in any stage of the life cycle of a medical device, from its design and development to its production, distribution, installation and after-sales service. This includes medical device manufacturers, component suppliers, distributors and related service organizations.

Organizations working in the manufacturing and distribution of medical devices often seek ISO 13485 certification to demonstrate their commitment to the quality and safety of their products.


ISO 13485: regulatory framework


Within the regulatory framework, it is one of the harmonized standards within the current European regulation of medical devices and in vitro medical devices.

As for the FDA (US regulations), it is currently in the process of updating its regulation regarding the quality management system to adapt to ISO 13485.


Do you need help implementing the ISO 13485 standard?


If you need to implement a quality management system under the ISO 13485 standard, at SQS we can help you.


Access free ISO 13485 self-assessment tool


SQS makes a self-assessment tool available to the network for companies considering obtaining 13485 certification.

It has been designed with the intention of highlighting the key aspects that have the greatest impact on the application of the standard. This selection has been made with the aim of helping companies prioritize tasks and have a preliminary indication of the effort required.

Please note that answers to questions are not saved, so be sure to download or screenshot the results before closing the quiz window.


ISO 9001

ISO/IEC 27001

ENS-nivel medio

ISO 20000


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