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 […]
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 […]
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 […]
The Ripple Effect: Re-Defining the Medical Device With state-of-the-art medical devices already making waves around the world, it may seem elementary to raise the matter of medical device definition. Yet, innovation has brought uncertainty to whether a product should be defined as a medical device. This is an important matter because medical devices need regular […]
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 […]
Comparison of Medical Mobile Apps Regulatory Frameworks Influencer healthcare authorities the largest being the US Food and Drug Administration and the European Commission are taking a cautious approach to regulating medical mobile apps. Most medical mobile apps or stand-alone software that run on mobile devices are considered as having low risk, and not subject to […]
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 […]
Five Points to Note when Supplying to the Healthcare Sector Like any other industries, the healthcare sector sits amidst a supply chain that manages the supply of manufacturing inputs and the delivery of product outputs to patients. From medical supplies such as nitrile gloves and testing kits to the medical equipment, the healthcare sector is […]
