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  • By Oxford Certificate
  • November 8, 2021
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Medical Equipment Quality ISO 13485 Topics E-Learning

Virtual training on quality medical equipment ISO 13485: Medical equipment and laboratory diagnostic equipment (IVDD) are very important because of the impact they have on the health and health costs of each country. A variety of products from simple bands, implants, diagnostic equipment and health conditions to the most sophisticated medical imaging equipment. And the smallest surgical instruments, which are divided into risk classes A, B, C and D, are audited in this standard. ISO 13485 – “Medical Equipment – Quality Management Systems – Requirements for Regulatory Objectives” is an internationally recognized standard for quality management systems in the medical equipment industry.

more details:
ISO 13485 is a standard from the International Organization for Standardization, published in 2003. Which indicates the requirements for a quality management system for medical equipment. The International Medical Equipment Quality Standard ISO 13485 sets out the requirements of a quality management system for an organization. Which needs to prove its ability to provide medical equipment and provide relevant services in accordance with customer needs and laws related to medical equipment and related services. ISO 13485 standard as a standard related to ISO 9001, states the requirements of quality management system in the design, development, production, assembly and after-sales service of all types of medical equipment. This standard addresses all of the GMP Good Manufacturing Practices that are widely available in these industries.

Virtual training course topics on ISO 13485 medical equipment quality topics:

  • Medical equipment management
  • Criteria for purchasing medical equipment
  • Medical equipment classification criteria
  • Requirements of ISO 13485
  • Quality control in medical laboratories
  • Laboratory equipment maintenance guide
  • Quality control of automatic cell counter devices

Prerequisites for the training course on the quality of medical equipment ISO 13485:

  • This course does not require special prerequisites and is taught from the ground up.

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