Items Tagged with 'ISO 13485'

In February 2024, the FDA took a bold step that will change the regulatory landscape of the medical devices industry as we know it.

Accumold announced that it has achieved successful ISO 13485 recertifiction, a globally recognized quality management standard for the medical device industry.

Listen to the latest podcast with Sai Ranjith, a quality engineer with over eight years of experience in the medical device industry. He focuses on regulatory compliance and risk management. He has a Six Sigma green belt and is an ISO 13485:2016 Medical Device Auditor. He also serves as program chair for the Granite State Chapter of ASQ.

Quality is honored to name Attrayee Chakraborty as our 2025 Quality Rookie of the Year. Discover how she earned the award through her groundbreaking work in medical device quality and AI integration.

Tips to take the mystique out of the internal audit process. The examples provided give you insight into the 3^rd party auditor’s perspective.

The quality environment has evolved to require the use of a risk based approach throughout the quality management system.

New changes to ISO 13485, published this spring as EN ISO 13485:2016, mean U.S. medical device companies that sell in Europe will need to integrate risk-based approaches throughout their quality management systems. The emphasis on risk management is the biggest of several changes in the third version  of ISO 13485.