Let me direct you to “Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers – Part 2: Regulatory Auditing Strategy”. Use all these guides ...

In particular, FDA’s final rule maps more closely to the global industry standard ISO 13485:2016, to address quality system management throughout the medical device life cycle, including design ...

Every new medical device feature must live within a quality management system that tracks design control, risk management, ...

This article focuses on the common regulatory threads that connect different regions and the global standards and principles ...

Quality. It’s difficult to assign a single definition to a word that carries many connotations. Instead, let’s look at quality as an experience. There is a vibration to it. It’s palpable.

Quality Management Systems (QMS) are integral for medical device manufacturers as they ensure adherence to regulations and help in producing top-quality products. Utilizing the right QMS software ...

Blake Webb shares trends in automation and microfluidics that are reshaping medical diagnostics and laboratory processes.

Lithoz has announced that its quality management system is now certified to ISO 13485 standards, marking a significant milestone in the company's commitment to providing high-performance 3D printing ...

“It is observed that the scope for conformance of quality management system for manufacturing of such medical devices is not included in the above said rules,” the minutes of the DTAB ...

We are committed to advancing this technology to improve patient outcomes, quality ... medical-announces-fda-breakthrough-device-designation-for-coloseal-intraluminal-colonic-diversion-system ...