Associação C.C.G. / ZGDV - Centro de Computação Gráfica

To provide a guidance framework for the development of regulated medical software.

Creation, updating or validation of technical materials related to systems or software, which must include description and specification of the device (software), instructions for use in the languages where the device (software) is expected to be sold, information relating to design and development, general safety and performance requirements, benefit-risk analysis and risk management, and product (software) verification and validation.

To perform all necessary tests to evaluate and confirm the software's compliance with specific norms, standards, and requirements, culminating in the issuance of a formal certification.