Why is ISO13485 beneficial for Medical 3D Printing?

ISO 13485 is an international standard specifically designed for medical device manufacturers, setting out requirements for a quality management system (QMS) that ensures the consistent design, development, production, and distribution of medical devices. While ISO 13485 is not specific to 3D printing, it provides numerous benefits when applied to medical 3D printing processes.

1. Quality Assurance: ISO 13485 helps ensure that medical manufacturing processes follow strict quality standards. By implementing a comprehensive QMS, it promotes consistency, reliability, and traceability in the production of medical devices such as using 3D printing technology.
2. Regulatory Compliance: Medical 3D printing is subject to regulatory requirements to ensure patient safety and product effectiveness. Adhering to ISO 13485 helps manufacturers demonstrate compliance with regulatory bodies such as the FDA (U.S. Food and Drug Administration) or the European Medical Device Regulation (MDR). These standards streamline the regulatory approval process, reducing time to market for medical 3D printed devices.
3. Risk Management: ISO 13485 emphasises risk management throughout the product lifecycle. Medical 3D printing involves various risks, such as material compatibility, accuracy, and validation. For example, manufacturers can identify, assess, and mitigate potential risks associated within the supply chain to ensure patient safety. For medical 3D printing, this ensures that material suppliers, post-processing partners, and any other outsourced services meet the required quality standards.
4. Enhanced Documentation and Traceability: ISO 13485 requires the establishment of comprehensive documentation, including design controls, manufacturing procedures, and quality records. This enables proper documentation of the medical 3D printing process, including design inputs, material specifications, equipment calibration, and post-processing steps. It facilitates traceability and helps identify any issues or non-conformities in the manufacturing process.
5. Continuous Improvement: ISO 13485 promotes a culture of continuous improvement and corrective actions. Frequent process evaluations help identify and implement corrective actions to constantly improve product quality and customer satisfaction.

In summary, ISO 13485 ensures quality, regulatory compliance, risk management, and continuous improvement in the field of medical 3D printing. It enhances patient safety, product effectiveness, and market acceptance of medical devices manufactured using 3D printing technology.

This is why Prototal UK have maintained this standard for so many years, and supported many medical companies develop their medical devices from prototype stage all the way through to production. The benefit 3D printing brings to our customers, is the ease of customisation for patient specific devices and guides.

If you need advice and support on your next medical project, please get in touch with the team at Prototal UK.

Email: info@prototaluk.com

Phone: 01635 635 855