Big Data

Leveraging Big Data in Medical Device Software: A Game-Changer for MedTech Startups

By Adam Newman

…a crucial role in regulatory compliance and risk management. By providing comprehensive and accurate data analysis, companies can ensure their products meet stringent regulatory standards and identify potential risks early…

…a crucial role in regulatory compliance and risk management. By providing comprehensive and accurate data analysis, companies can ensure their products meet stringent regulatory standards and identify potential risks early…

Continue reading

Health Equity

Health Equity Requires Awareness, Focus, and Collaboration: Industry Experts Agree

By Amra Racic

…devices requires comprehensive and accurate data demonstrating the device’s safety, effectiveness, and compliance with regulatory standards. “If we don’t have the clinical data and aren’t meeting compliance needs, the product…

…devices requires comprehensive and accurate data demonstrating the device’s safety, effectiveness, and compliance with regulatory standards. “If we don’t have the clinical data and aren’t meeting compliance needs, the product…

Continue reading

Japan Medical Device Reimbursement Update 2024

By Ames Gross

Fifteen years ago, medical device reimbursement in Japan normally created a very profitable business for many device companies. For example, at that time, if the device company had 10% of…

Fifteen years ago, medical device reimbursement in Japan normally created a very profitable business for many device companies. For example, at that time, if the device company had 10% of…

Continue reading

CERs

Why Clinical Evaluation Reports are Challenging and How To Streamline the Process

By Celegence

Clinical Evaluation Reports (CERs) are a crucial component in the regulatory submission process for medical devices, especially in markets like the European Union, where compliance with the EU Medical Device…

Clinical Evaluation Reports (CERs) are a crucial component in the regulatory submission process for medical devices, especially in markets like the European Union, where compliance with the EU Medical Device…

Continue reading

Virtual care

AI-Enabled Healthcare: How Quality Engineering Needs to Evolve to Meet New Challenges

By Qualitest

…transparency. Ensure that security measures are transparently communicated to build trust in the system’s data protection capabilities. Ethical guidelines, governance and regulatory compliance Ethics Develop clear ethical guidelines for the…

…transparency. Ensure that security measures are transparently communicated to build trust in the system’s data protection capabilities. Ethical guidelines, governance and regulatory compliance Ethics Develop clear ethical guidelines for the…

Continue reading

compliant claims
CAPA Corner

Mastering the Complexities of Medical Device Claims

By Michelle Lott

Navigating the complexities of medical device marketing is challenging, with strict regulations governing what companies can and cannot claim about their products. Even well-intentioned organizations can encounter compliance issues. One…

Navigating the complexities of medical device marketing is challenging, with strict regulations governing what companies can and cannot claim about their products. Even well-intentioned organizations can encounter compliance issues. One…

Continue reading