ISO 13485 in Medical Electronics Manufacturing


Producers must demonstrate that each product they make meets customer expectations and applicable legal requirements. This is especially true in the highly regulated medical device manufacturing sector (also known as medical electronics manufacturing). Therefore, medical device companies have to make a very responsible decision and consider many important factors when looking for a PCB design and assembly partner. After all, the life and health of end-users depend on the quality of the manufactured products. Therefore, the most important and, at the same time, the most challenging task is to find an experienced PCB manufacturer with the ISO 13485 certification.

The ISO 13485 standard is broadly recognized on the international market. Applying it in a company makes it possible to demonstrate that the organization conducts its activities in an organized and comparable manner, supervises its processes, develops them, and, through the application of requirements, controls and minimizes the occurring risks, but also manages and reduces potential risks.

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An organization with an implemented and certified ISO 13485 management system inspires trust both among customers and authorities supervising its activities. Working with a certified PCB manufacturer can help OEMs meet quality system regulatory standards and current good manufacturing practices. Let’s find out why this standard is so important and what it is evidenced by.

What is the ISO 13485 standard?

The ISO 13485 standard (Medical devices – Quality management systems – Requirements for regulatory purposes) is an internationally recognized standard for quality management systems in the medical device manufacturing industry. This standard specifies the requirements for a quality management system for organizations that must demonstrate their ability to provide medical devices and related services in a manner that consistently meets customer requirements and applicable legislation. It was developed for organizations in the design and development, production, installation, and service of medical devices. As this industry is strictly regulated worldwide, the original aim of ISO 13485 is to harmonize medical device legislation requirements with quality management systems.

Implementing ISO 13485 is based on analyzing the possible risk for users of medical devices and the development of corrective methods to prevent this risk and adapt the offered products to the applicable legal standards. The implementation of ISO 13485 should include:

  • Company analysis in the form of Zero Audit
  • Development of the implementation schedule
  • Implementation of the system
  • Training for managers and employees
  • ISO 13485 Internal Auditor training
  • Performance of internal audits
  • Preparation for certification

ISO 13485 and ISO 9001

ISO 13485 is a standalone Quality Management System standard derived from the internationally recognized and accepted ISO 9000 series of quality management standards. ISO 13485 adopted the ISO 9000 process model for the regulated environment of medical device manufacturers. While ISO 13485 is primarily based on the ISO 9001 PDCA (Plan-Do-Check-Act) framework, it includes some practical medical device requirements, such as risk analysis, sterile manufacturing, and traceability. It eliminates specific requirements of ISO 9001, which are not essential as legal requirements. It is designed for regulatory compliance.

This standard is more detailed and requires a carefully documented Quality Management System. ISO 13485 was written to support medical device manufacturers in developing quality management systems that establish and maintain the effectiveness of their processes. This standard ensures the consistent design, development, production, installation, and delivery of safe medical devices for their intended use.

ISO 13485 is a guarantee of trust

This norm’s certification of the quality management system is an assessment of the implementation and maintenance of compliance with ISO 13485. The ISO 13485 standard aims to ensure the safety of a medical device, ensuring the safety of patients and people using the device. Although this standard does not require continuous improvement from PCB manufacturers and does not require evidence of customer satisfaction assessment, continuous improvement has been replaced here with implementing and applying a risk management system, which is essential from the point of view of the OEM. The management system compliant with ISO 13485 imposes the obligation to assess risks and eliminate identified and potential risks and risk management. Thus, obtaining the ISO 13485 certificate proves both the organization’s competitiveness and high-level production capacity both on the domestic and international market.

Is ISO 13485 certification mandatory?

The implementation and certification of ISO 13485 are required by European Community law. Therefore, organizations that market their products following European directives must have an implemented and certified management system quality for medical devices, ISO 13485. In other cases, certification may not be necessary. For example, the manufacturer does not need to be ISO 13485 certified to meet its standards. And it does not need ISO 13485 certification to manufacture and sell medical device components or finished devices. However, medical device manufacturing certification tells everyone, including regulators and customers, that your electronic components have been objectively assessed by a third party and meet all requirements for producing safe goods.

An electronics manufacturer can be part of an extended supply chain and, with ISO certification for medical devices on their side, ensures customers that part of their process is to the highest standards.

Recertification every 3 years

Finally, it is worth emphasizing that the ISO 13485 certificate is issued for 3 years. In the second and third years, the PCB manufacturer is required to conduct a surveillance audit to optimize the processes related to the production of medical devices. After three years, a recertification audit is carried out. Joining the procedure confirms the company’s involvement in the Quality Management System for Medical Devices.

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Why are we writing about it?

ISO 13485 proves that each element of the manufactured medical device meets the most stringent safety standards. Entrusting PCB assembly to a certified EMS guarantees the highest quality of services and gives a sense of peace and security. There are no jokes about the production and distribution of medical equipment. Hospitals and other healthcare facilities cannot use products which components may not work correctly. After all, there is a fight for the life and health of other people. Therefore, the PCB manufacturer’s documentation must meet strict medical requirements to be trusted with its assembly services.

As above, if you are an OEM manufacturer and you want to establish cooperation with a contracted manufacturer of electronics or other devices intended for medical purposes, you should first ask your potential partner whether they have a current ISO 13485 certificate. We recommend that you do not try to establish cooperation with companies that do not have such a certificate.

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