Quality Systems
for Medical Devices
Continuous improvement focused on customer satisfaction.
Fill the form and wait
for a consulting pro.
Quality Systems for
Medical Devices
Continuous improvement focused
on customer satisfaction.
Control and standardization
In view of the complex regulation of medical device manufacturing, the implementation of quality management systems is essential.
And when it comes to quality management systems, certification is a way to ensure production control and standardization.
Control and standardization
In view of the complex regulation of medical device manufacturing, the implementation of quality management systems is essential.
And when it comes to quality management systems, certification is a way to ensure 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 process effectiveness and compliance. It can be said that an QMS acts as a set of elements that meet the organization’s Quality Policy and international quality standards, aiming 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 ensure the quality and regulatory compliance of medical devices.
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 process effectiveness and compliance. It can be said that an QMS acts as a set of elements that meet the organization’s Quality Policy and international quality standards, aiming 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 ensure the quality and regulatory compliance of medical devices.
What is ISO 13485?
Following the premise of ISO 9001, ISO 13485 was developed as an autonomous standard aimed at
to medical devices. Its focus is to support manufacturers in the development of management systems
of quality that establish and maintain the effectiveness of their processes.
Based on the ISO 9001 PDCA process model, it is designed for regulatory compliance.
In this way, it is naturally more prescriptive and needs a quality management system
best documented. This certificate guarantees benefits such as:
Free
commerce
Consistent
quality
Risk
management
What is ISO 13485?
Following the premise of ISO 9001, ISO 13485 was developed as an autonomous standard aimed at to medical devices. Its focus is to support manufacturers in the development of management systems of quality that establish and maintain the effectiveness of their processes.
Based on the ISO 9001 PDCA process model, it is designed for regulatory compliance. In this way, it is naturally more prescriptive and needs a quality management system best documented. This certificate guarantees benefits such as:
Free commerce
Consistent quality
Risk management
How can QR Consulting help you in this process?
Making everything easier through:
How can QR Consulting help you in this process? Making everything easier through:
Check some of our clients:
Check some of our clients:
