See how QR Group’s Quality Assurance service ensures ISO 13485 standards and compliance with GMP and ANVISA standards

QR Group offers a complete quality-assured service, helping manufacturers implement quality management systems to ensure compliance with ISO 13485, RDC 39/2013 and RDC 15/2014. In this article, we explain how this service strengthens control and efficiency in the production of medical devices.

What is quality assured?

Quality assurance is a proactive process, based on documentation, audits and controls that prevents failures throughout the production cycle.

Why invest in this service?

• Cause and effect: Establishing robust processes reduces errors and rework.

• Clarification: ISO 13485 certification ensures standardization and reliable control.

• Emphasis: by combining technical and regulatory standards, the service strengthens the company’s reputation and competitiveness.

QR Group’s solution

a) Initial assessment

We mapped the existing system and found gaps in relation to ISO 13485, RDC 39/2013 and RDC 15/2014.

b) QMS Development

We structure quality management systems with documentation, risk analysis and operational procedures.

c) Training & audits

We train teams in GMP, ISO 13485, ISO 14971, CAPA and conduct internal audits to ensure complete compliance.

Target audience

• Medical device manufacturers seeking ISO 13485 certification and GMP compliance.

• Companies that want to ensure international standards and regulatory acceptance.

• Businesses that need to increase controls, reduce risks and strengthen their brand.

QR Group is a leader in quality assurance, implementing complete systems that ensure technical and regulatory compliance. If you want to ensure control, security and competitiveness, contact us and optimize your operations with excellence.

Fonte: QR Group