Quality systems
for medical devices
Find out how to obtain ISO 13485 certification and
the Brazilian Good Practices in accordance with RDC 665/2022.
Fill out the form and wait contact a consultant.
Quality systems for medical devices
Find out how to obtain ISO 13485 certification and
the Brazilian Good Practices in accordance with RDC 665/2022.
Control and standardization
In view of the complex regulations governing the manufacture of medical devices, the implementation of quality management systems is essential. And when it comes to quality management systems, certification is a way of ensuring production control and standardization.
Organizations have a duty to show that each device meets expectations and technical standards
Validating and certifying quality management systems (QMS) for medical devices is essential to maintaining the effectiveness and conformity of processes. It can be said that a QMS acts as a set of elements that comply with the organization’s Quality Policy and international quality standards, in order to meet market and regulatory expectations, with a focus on customer satisfaction.
The International Organization for Standardization (ISO) is responsible for publishing ISO standards, which are global references for standard-based certification and quality assurance. ISO 13485 is the standard used to guarantee the quality and regulatory compliance of medical devices. For the Brazilian GMP, the regulation that should be complied is the RDC 665/2022.
Control and standardization
In view of the complex regulations governing the manufacture of medical devices, the implementation of quality management systems is essential. And when it comes to quality management systems, certification is a way of ensuring production control and standardization.
Organizations have a duty to show that each device meets expectations and technical standards
Validating and certifying quality management systems (QMS) for medical devices is essential to maintaining the effectiveness and conformity of processes. It can be said that a QMS acts as a set of elements that comply with the organization’s Quality Policy and international quality standards, in order to meet market and regulatory expectations, with a focus on customer satisfaction.
The International Organization for Standardization (ISO) is responsible for publishing ISO standards, which are global references for standard-based certification and quality assurance. ISO 13485 is the standard used to guarantee the quality and regulatory compliance of medical devices. For the Brazilian GMP, the regulation that should be complied is the RDC 665/2022.
After all, what is ISO 13485?
Following the premise of ISO 9001, ISO 13485 was developed as a stand-alone standard aimed at medical devices. Its focus is to support manufacturers in developing quality management systems that establish and maintain the effectiveness of their processes. Based on the ISO 9001 PDCA process model, it is designed for regulatory compliance. Therefore, it is naturally more prescriptive and requires a better documented quality management system.
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