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 […]

Medical device scientist

How to Transition From Scientist to Entrepreneur Using Proven Business Roadmaps

How to Transition From Scientist to Entrepreneur Using Proven Business Roadmaps FROM ACADEMIA TO ENTREPRENEUR: LESSONS FROM THE REAL WORLD by Eugene Khor REVIEW The 13-chapter biomedical startup handbook From Academia to Entrepreneur: Lessons from the Real World written by Dr. Eugene Khor provides practical insights into the requisite business building blocks necessary for a […]

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 regulations

Here’s Why Medical Device Regulatory Compliance is a Business Decision

Here’s Why Medical Device Regulatory Compliance is a Business Decision On the part of the device manufacturer, following medical device regulations perfectly does not mean that all safety, quality and effectiveness parameters have been addressed. The US Food and Drug Administration recently looked into complaints about a permanent birth control device called Essure. A medical […]

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 […]

Medical Device design

Designing Medical Devices for Commercial Success

Designing Medical Devices for Commercial Success A healthcare startup CEO quoted wisely that “great medical technology does not necessarily lead to a sellable medical technology”. The market does not immediately fall head over heels with new medical device technology. Technological pursuits, debates and accomplishments among research circles do not necessarily include the voice of the […]