ISO 13485 standard - is it necessary in medical devices?

ISO 13485 is a standard created especially for manufacturers of medical equipment. Although it is not necessary in the case of medical devices, it is very important from the perspective of contractors deciding to purchase equipment. Equipment that meets the ISO 13485 standard is, therefore, better perceived by customers, which leads to maximization of profits on the part of the manufacturer. ISO 13485 certification is often required from companies offering EMS services due to the need to supervise the entire PCB assembly process in accordance with the requirements of the standard. The assembly process in SMT and THT technology is subject to supervision, as well as the need to carry out testing procedures such as AOI, SPI, functional tests, as well as visual inspection, and final tests. The packaging process is also verified.

What exactly is the ISO 13485 standard?

The standard is based on the general standard of the quality management system. The ISO 9001 standard was therefore the foundation on which a new standard was created, adapted to the specificity of medical devices. The standard affects the consistent design, quality control, production, assembly, and delivery of medical devices to the end customer. Devices compliant with the ISO 13485 standard are to give the customer a guarantee of 100% safety and reliability.

Why is ISO 13485 certification important?

Of course, medical devices are subject to strict quality control, taking into account that they will eventually be used to treat and save lives. Before medical devices can be used, they must obtain a number of certificates. The ISO 13485 standard is not necessary for such a product to be placed on the market, however, it significantly facilitates obtaining the appropriate permissions. The certificate may be issued by a company notified by the European Commission.

The committees responsible for certifying medical devices pay great attention to compliance with the international ISO 13485 standard. It is a kind of seal that confirms that the product was made in accordance with the highest quality and safety standards. To sum up, a manufacturer with an ISO 13485 certificate can count on shorter formalities related to obtaining other certificates confirming the compliance of the product with the applicable regulations.

What are the benefits of ISO 13485 certification?

ISO 13485-certified manufacturers are better perceived by both customers and regulatory approval committees. For both parties, there is information that medical devices are subject to a careful and orderly production process, from design, through manufacturing, assembly, to transport and installation in a medical facility. The valid ISO 13485 certification is, therefore, an important advantage over competing manufacturers who do not have such certification.

The international ISO 13485 standard offers unlimited access to the global market and the possibility of establishing cooperation with contractors from many countries. The certificate certifies compliance with market requirements and reduces the time needed to obtain other certificates and permits needed to place medical devices on the market. Production signed with this certificate is also much more efficient and less expensive. To sum up, manufacturers of medical devices compliant with ISO 13485 standards can count on minimizing production costs, a positive image in the eyes of contractors, and maximizing profits.

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