Quality control

Quality control in the manufacture of IVD medical devices is a key element in ensuring patient safety and product compliance with legal requirements and industry standards. The manufacture of medical devices should meet the requirements of the ISO 13485 quality standard to ensure that the product is safe, effective and reliable in use.

Quality control takes place at every stage of production, including:

• the design process
• the procurement process for raw materials and services
• the production process
• the logistics process
• supervision of the manufacturing environment
• complaints and returns management
• product supervision
• qualifications and validations

Quality control in the manufacture of medical devices is a complex process that requires the implementation of appropriate procedures, precise management and compliance with regulations. Effective quality control ensures that the final product will meet all standards and expectations, minimising the risk of errors and ensuring patient safety.