Health products are increasingly important in the area of ​​health, in relation to their impact on the patient’s health as well as health care expenses. Therefore, having an ISO 13485 Certification of medical devices is of vital importance.

Sanitary products cover a wide range of products. From bandages, implantable devices, equipment for the detection and diagnosis of diseases or the most advanced surgery equipment.

What is the ISO 13485 standard?

ISO 13485 is an internationally recognized standard for quality management systems in the medical device industry.

It specifies all the requirements to implement a quality management system where a company must be able to demonstrate its ability to provide health products and related services.

These services must comply in a consistent manner with customer requirements and applicable regulations.

The ISO 13485 certification for manufacturers of medical devices is designed and conceived to use in organizations for the design and development, production, installation, services and sales of medical devices.

Objectives of the ISO 13485 certification for medical device manufacturers

The main objective of ISO 13485 is to facilitate medical devices harmonized regulatory requirements for quality management systems.

ISO 13485 is an independent standard. It is based on the structure of ISO 9001, but includes the particular requirements for medical devices such as risk and traceability analysis.

Advantages of ISO 13485 certification

When the company intends to provide service in the design, development, production, installation, services and sales of medical devices, this certification will help you in your objective.

Companies with this certification are transmitting, with this certification, a guarantee of quality and responsibility to both customers and regulators.

Other advantages for the company of having the ISO 13485 certification are:

  • Increasing access to international markets with certification
  • To establish a system of continuous improvement in the organization
  • To increase efficiency, reducing costs and controlling the supply chain performance
  • To guarantee safer and more effective production of health products
  • Comply with current regulations and customer expectations

I.P. Triana, an ISO 13485 certified company as a manufacturer of medical devices

Industrias Plásticas Triana is a company certified with ISO 13485, as well as other certifications and quality seals in different business areas.

Contact us to know more about our products, services and associated quality certification seals.

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