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Medical Device Compliance Technical File

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…

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How to Transition From Scientist to Entrepreneur Using Proven Business Roadmaps

FROM ACADEMIA TO ENTREPRENEUR: LESSONS FROM THE REAL WORLD by Eugene Khor Get MedTech Book Recommendations: REVIEW The 13-chapter biomedical startup handbook From Academia to Entrepreneur: Lessons from the Real…

Great Wall of China's Medical Device Regulation

The Great Wall of China’s Medical Device Regulation

Get copies in PDF  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…

Business decision

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

The US Food and Drug Administration recently looked into complaints about a permanent birth control device called Essure. A medical team from Weill Cornell Medicine in New York reported a…

The Ripple Effect - Medical Device Definition

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…

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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…

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The Five Success Factors of a Digital Health Product from this CEO

Rosaline Koo took a leap of faith in 2013 and invested USD$4 million of personal funds to build a health insurance startup, ConneXionsAsia (CXA). The health insurance industry was not…

Medical Tourism

Some Guidance on Running a Healthcare Startup from this CEO

After spending 7 years in Temasek Holdings as an investor, Cole Sirucek took a career change that landed him the title of CEO in a healthcare startup. He demonstrates the…

Medical device design

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…

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Comparison of Medical Mobile App 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 mobile apps or…