ABNT NBR ISO 13485

NCC is the first Brazilian OMD accredited to conduct the MANAGEMENT SYSTEM CERTIFICATION FOR HEALTH PRODUCTS based on the ABNT NBR ISO 13485 standard.

ISO 13485, derived from the internationally recognized and accepted ISO 9001, specifies the quality management system requirements that can be used by an organization involved in one or more stages of a medical device’s lifecycle, including design and development, production, storage, and distribution, installation, technical assistance, discarding, and final disposal.

The implementation and certification of ISO 13485 for companies seeking to enter or already operating in the medical device sector bring the following advantages:

• increases access to global markets with certification;
• demonstrates that you produce safer and more effective medical devices;
• improves internal processes and decision-making;
• creates a culture of continuous improvement;
• demonstrates a commitment to safety and quality;
• demonstrates the ability to meet customer and legislative requirements.

 

Preparing for certification means implementing a quality management system that complies with the medical industry’s laws and regulations and demonstrating your ability to provide medical devices and services consistently with applicable regulatory requirements. NCC is a certification body accredited by Cgcre (General Coordination for Accreditation of Inmetro) and can meet your certification needs.  

How the process works: 

Como funciona o processo:

 

 

  For more details, contact NCC: Michele Moreira +55 19- 97826-9596.