Internal Audits and
Inspections on Suppliers

Get ready to the registration of yours medical devices.

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for a consulting pro.

Internal Audits and Inspections on Suppliers

Get ready to the registration of yours
medical devices.

Understand how Anvisa's GMP inspection works

For the registration of risk class III and IV products, it is necessary to carry out an Inspection of Good Manufacturing Practices by ANVISA at the manufacturer’s facilities, whether national or international. This inspection is mandatory for the release of the record.

Understand how Anvisa's GMP inspection works

For the registration of risk class III and IV products, it is necessary to carry out an Inspection of Good Manufacturing Practices by ANVISA at the manufacturer’s facilities, whether national or international. This inspection is mandatory for the release of the record.

What are good
manufacturing practices?

GMP is one of the main mechanisms to ensure the quality of a medical device. Ensures that products are consistently produced and controlled, with appropriate quality standards for the intended use and required by the registry.

Failure to comply with GMP can lead to the manufacture of a medical device that does not meet the appropriate quality standards, compromising the safety and efficacy of the product.

What are good manufacturing practices?

GMP is one of the main mechanisms to ensure the quality of a medical device. Ensures that products are consistently produced and controlled, with appropriate quality standards for the intended use and required by the registry.

Failure to comply with GMP can lead to the manufacture of a medical device that does not meet the appropriate quality standards, compromising the safety and efficacy of the product.

Why is it important to have the GMP certification?

ANVISA requires GMP certification for the distribution of class II and IV
medical devices, requiring an inspection.

Why is it important to have
the GMP certification?

ANVISA requires GMP certification for the distribution
of class II and IV medical devices, requiring an inspection.

How QR Consulting can help you on this process?

QR Consulting performs pre-audit inspections by ANVISA (Gap analysis) at manufacturers’ facilities
as the purpose of verifying compliance with the requirements of RDC 16 – Good Manufacturing and Control Practices.

How QR Consulting can
help you on this process?

QR Consulting performs pre-audit inspections by ANVISA (Gap analysis) at manufacturers’ facilities
as the purpose of verifying compliance with the requirements of RDC 16 – Good Manufacturing and Control Practices.

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.