- info@dascertification.org
- +14379084992
ISO 13485 standard is an international standard for quality management systems in the medical device industry. This standard helps medical device manufacturers comply with legal and health requirements and ensures the hygiene and durability of medical products. This standard emphasizes risk management, design, production, and distribution of medical devices and helps your organization establish an effective quality management system in the medical device industry. Next, we’ll explain in more detail what is ISO 13485 standard.
The ISO 13485 standard focuses on aspects such as risk management, design, production, and distribution of medical devices. Compliance with these points helps your organization guarantee the quality of your medical products and comply with important legal and health requirements in the production process. This standard also focuses on continuous process improvement and increased safety of medical products, which increases trust among your patients and customers.
The ISO 13485 standard is applicable to all organizations active in the medical device industry, including your organization that includes manufacturers to distributors. This standard helps your organization manage a quality production process of medical products and gain the trust of patients, customers, and regulatory bodies. By obtaining this standard, your organization can enter competition in global markets.
Obtaining ISO 13485 certification demonstrates your commitment to the safety and quality of your organization’s medical device products. This standard not only helps improve the quality of medical products, but also increases trust among patients, customers, and regulatory bodies. Organizations that receive this certification, including you, can benefit from advantages such as increased credibility, greater competitiveness, and consequently the ability to access and enter new markets.
