What is ISO 13485?

The ISO 13485 quality management standard focuses on medical devices and is essential to certify their adaptability for professional use. Therefore, the characteristics and usefulness of this certification are discussed in the following sections.

ISO 13485, definition and objectives

It is used in systems to manage each industrial process in the sector dedicated to the manufacture of devices for medical use. Likewise, it evaluates everything related to the creation, installation and sale of health products. Among its objectives are the following:

• Control of production from the moment an item is designed until it is manufactured. Special attention is paid to the sterilization of each material, its packaging or the way of storing the products.
• The management of possible risks that may appear throughout its useful life. Attention is paid to the risks that may arise during manufacturing and to the safety of the process.
• Control of everything related to suppliers and subcontractors involved in the production and distribution of the product.
• Compliance with legislation when using the clinical data used to create the product.
• Monitor the evolution of the product when it is put on sale.
• Obtaining the results that confirm that the quality control is ideal.

The combination of the above factors makes it easy for each item to be fully monitored and immediate action can be taken in the event of a problem.

What is its importance?

It is intended for all companies dedicated to the supply of medical devices and related services. In other words, it is exhaustively assessed that the demands of the end customer and the regulations in force are met. The productive capacity of the company is indifferent.

Its importance lies in the fact that it determines the necessary basis for a manufacturer to understand what its responsibility is and what the current regulations require of it. Likewise, the text underlines the commitment to quality and safety of each reference. The priority is that the standard does not focus on a single product, but on all those that belong to the same market niche.

In general, the legislation of each country requires compliance with this standard to approve the sale of a medical device. Plus, it helps work with companies with more resources, confirms a commitment to quality, and shows customers that the manufacturer cares about safety and compliance with the law.

At Electro Lomas, we comply with the ISO 13485 quality management standard and support is provided to the client who requests it in the manufacture of a medical product, as well as in everything related to the relevant electronic circuits so that an article works as expected. On our website and in the different profiles available on social networks it is possible to request more information about our professional services. Everything is to bring to the market an article for medical use with the highest possible quality.