Risk-based approach

Using a Risk-Based Approach to Quality Management System for Medical Devices

Using a Risk-Based Approach to Quality Management System for Medical Devices The risk-based approach has always underpinned the design, manufacture, control and regulation of medical devices. In most jurisdictions, medical devices are classified based on risk. Higher risk medical devices are subjected to more extensive regulatory scrutiny. This means there is greater demand for comprehensive […]

Medical Device Compliance

Stop Reforming Medical Device Regulations

Stop Reforming Medical Device Regulations The Year of Regulatory Reforms 2016 is a year of contemplation for medical device regulatory reforms triggered by scandals and recalls of the recent past years. As the PIP breast implant controversy is being fought in the courts today, European regulators published the first draft of the new EU medical […]

China Medical Device Regulation

The Great Wall of China’s Medical Device Regulation

The Great Wall of China’s Medical Device Regulation The tightening of medical device regulations in China shows that access to its vast market opportunities demands watertight accountability for product safety and effectiveness from foreign suppliers. Understandably, China will not be used as a “dumping ground” for cheap medical devices from sub-standard manufacturers. However, China’s recent […]

Medical Device Regulatory Rules

The Less Burdensome Pathways to US FDA Approval

The Less Burdensome Pathways to US FDA Approval The most contentious hurdle that steals competitiveness and commercial opportunities for medical devices is the regulatory review process. It has already been very challenging for regulators to strike a balance between assuring device safety and ensuring access to the best treatment. However, where regulations threaten to stifle […]

Quality Management

The 10 Key Chief Quality Officer Job Responsibilities for Medical Technology

The 10 Key Chief Quality Officer Job Responsibilities for Medical Technology 1. Propagate quality responsibilities The position of Chief Quality Officer (CQO) should be a permanent and dedicated role in small medical technology businesses. A CQO provides strategic quality management vision for product development and manufacturing. He or she ensures that quality assurance is an […]