E-Learning & Certification on ISO 13485 medical equipment quality topics: medical equipment and laboratory diagnostic equipment (IVDD) are very important because of their impact on health and health costs of each country. Various products including simple bandages, implantable equipment in the body, display equipment for diagnosing diseases and health conditions to the most complex medical imaging equipment. and the smallest surgical instruments that are in risk classes A, B, C and D are divided, in the audit scope of this standard. ISO 13485 – “Medical devices – Quality management systems – Requirements with regulatory purposes” is an internationally recognized standard for quality management systems in the medical device industry.

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ISO 13485 is a standard of the International Organization for Standardization that was published in 2003. which indicates the requirements for the quality management system for medical equipment. The ISO 13485 international quality standard for medical devices defines the requirements of a quality management system for an organization. which needs to prove its ability to supply a medical equipment and provide relevant services in accordance with the requirements of customers and the laws related to medical equipment and related services. The ISO 13485 standard, as a standard related to ISO 9001, states the requirements of the quality management system in the design, development, production, assembly and after-sales services of all types of medical equipment. This standard takes into account all the requirements of GMP (Good Manufacturing Practices) widely used in these industries.

Course headings E-Learning & Certification ISO 13485 medical equipment quality topics: