ISO 13485. 

At the end of the training, trainees will be able to:

• Evaluate the design, implementation and improvement according to the requirements of ISO 13485;
• Understand the importance of Device Certification - ISO 13485 and its focus on organizational development;
• Assess the particularities of medical devices that are required to meet the requirements of the Medical Device Certification;
• Apply the requirements to a company whether it is involved in the design and development, manufacturing, packaging, manuals, installation or maintenance of medical devices;
• Equipping trainees with knowledge about the management of Device Certification - ISO 13485, the main legal requirements applicable in Portugal and understand the process of legal conformity assessment;
• Plan, prepare and perform internal audits for the standard of Device Certification - ISO 13485.