ISO 13485

Why ISO 13485?

ISO 13485 is an international standard developed specifically for companies that manufacture, develop and distribute medical devices. The standard specifies quality management system (QMS) requirements to ensure that products meet legal requirements and customer expectations.

A QMS according to ISO 13485 can help improve the safety and effectiveness of medical devices by ensuring a structured and systematic approach to product development and manufacturing. The standard also specifies requirements for monitoring and measuring processes to ensure that products meet the specified requirements.

In many countries, compliance with ISO 13485 is a requirement for the sale of medical devices on the market. By implementing a QMS according to ISO 13485, companies can ensure compliance with legal requirements and customer satisfaction, which in turn can help increase the company's reputation and competitiveness.

Using ISO 13485 can be beneficial in projects involving the development and manufacturing of medical devices. The standard provides a framework for a quality management system that ensures that products meet customer requirements and legal regulations.

By implementing a QMS in accordance with ISO 13485, a company can improve the quality of its products and processes and thus increase the satisfaction of its customers. A well-designed and implemented QMS can also help minimize risks and gain the trust of regulators and customers.

Overall, using ISO 13485 in projects can help ensure that the medical devices that are developed and manufactured are safer, more reliable and of higher quality.

Back to the blog