ISO 13485 for Medical Devices

Relevant for every organization in the medical device field

People rely on medical devices to survive; if your company operates in the medical device sector, quality is essential. ISO 13485 certification can help you demonstrate your ability to provide medical devices and related services that meet customer requirements and regulatory standards.

ISO 13485 defines the requirements for a quality management system that every organization in the medical device sector must comply with. Certification demonstrates the reliability of your company and proves your commitment and capabilities to provide design, manufacturing, testing, and distribution services that meet customer needs and regulatory requirements.

What you need to know

Based on the more general quality management standard ISO 9001, ISO 13485 is specifically aimed at organizations in the medical device sector, covering all phases from design through installation and maintenance to related services such as sterilization and testing.

It specifies the requirements for a quality management system for medical devices. In the EU, these requirements have been harmonized with various directives, including the Medical Device Directive (93/42/EEC), the In Vitro Diagnostic Directive (98/79/EC), and the Active Implantable Medical Devices Directive (90/385/EEC).

ISO 13485 follows a structure that makes it easy to apply alongside other management system standards such as ISO 14001.

Certification with Kiwa

Safety and quality are non-negotiable in the medical device industry – they can literally mean the difference between life and death. With increasingly strict regulatory requirements and the rising expectations of customers and organizations throughout the supply chain, it is essential to demonstrate best practice in quality management processes – and this is exactly what ISO 13485 certification delivers.

Through a partnership with Kiwa, ISO 13485 certification ensures that your products or services in the medical device sector comply with internationally recognized standards, helping you gain customer trust and meet regulatory requirements.

ISO 13485 was last updated in 2016; if you were previously certified, you had until March 2019 to transition to the new standard. Kiwa can help you with the transition – contact us to learn more.

USPs / Benefits

• Win new business – Outperform competitors in procurement processes where ISO 13485 certification is required.
• Improve your processes – Identify improvement potential in your management processes with ISO 13485 and ensure their international acceptance.
• Reduce your costs – ISO 13485 helps you reduce operational, manufacturing, and energy costs by showing where processes can be optimized.
• Meet customer needs – With a customer-focused approach, ISO 13485 enables you to set targets to fulfill customer requirements.
• Show your commitment to quality – ISO 13485 certification demonstrates to customers, partners, and employees that you are committed to continuous improvement.
• Enhance your competitiveness – ISO 13485 certification helps you access new global markets and supply chains and establish new business relationships.
• Monitor and improve your performance – ISO 13485 helps you analyze processes and track customer feedback.
• Manage your supply chain – ISO 13485 covers supply chain management and supports you in improving processes while maintaining quality across the entire value chain.