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:

Adequacy of the quality system in relation to current Brazilian regulatory standards applicable to medical products (RDC 16 - Good Manufacturing and Control Practices ANVISA and IN 08/2013

Procedures for granting Good Practices according to RDC 39/2013 and RDC 15/2014

Adequacy of the quality system in relation to ISO 13485

Carrying out internal audits on manufacturers for alignment and adequacy according to RDC 16/2013

    How can QR Consulting help you in this process? Making everything easier through:

    Adequacy of the quality system in relation to current Brazilian regulatory standards applicable to medical products (RDC 16 - Good Manufacturing and Control Practices ANVISA and IN 08/2013

    Procedures for granting Good Practices according to RDC 39/2013 and RDC 15/2014

    Adequacy of the quality system in relation to ISO 13485

    Carrying out internal audits on manufacturers for alignment and adequacy according to RDC 16/2013

      Check some of our clients:

      Check some of our clients:

      A full structure dedicat to te development of your business.

      A full structure dedicat to te development of your business.

      Fill the form and wait for a consulting pro.