Ameing for Asia

Pollution Chokes Asia, Increases Medtech Opportunities

By Ames Gross

…warnings stating air pollution has reached unhealthy levels. The Medtech Opportunity Medtech companies that can provide products to help patients combat pollution are in high demand. Nebulizers are frequently used…

…warnings stating air pollution has reached unhealthy levels. The Medtech Opportunity Medtech companies that can provide products to help patients combat pollution are in high demand. Nebulizers are frequently used…

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FDA

FDA Releases Proposed List of 510(k) Exempt Class II Devices

By MedTech Intelligence Staff

FDA has compiled a document containing more than 1000 Class II devices that the agency is suggesting be exempt or partially exempt from 510(k) requirements. Listed in the Federal Register,…

FDA has compiled a document containing more than 1000 Class II devices that the agency is suggesting be exempt or partially exempt from 510(k) requirements. Listed in the Federal Register,…

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Michael Lohan, IDA Ireland
Soapbox

Ireland’s Medtech Industry Will Benefit from Brexit

By Michael Lohan

…While the UK is Ireland’s close neighbor and biggest trading partner, the countries have been rivals in the competition for new investments by medical device companies and biopharma businesses. Today,…

…While the UK is Ireland’s close neighbor and biggest trading partner, the countries have been rivals in the competition for new investments by medical device companies and biopharma businesses. Today,…

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Cybersecurity, mhealth

Protecting Products in the Face of Cybersecurity Vulnerabilities

By Maria Fontanazza

…doing right when it comes to addressing cybersecurity? Elan: Companies are starting to ask good questions and examine and understand the environment of risk. We are also seeing regulators respond…

…doing right when it comes to addressing cybersecurity? Elan: Companies are starting to ask good questions and examine and understand the environment of risk. We are also seeing regulators respond…

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Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Training, Training, and More Training

By Dr. Christopher Joseph Devine

…FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (February 2017). Inspections, Compliance, Enforcement, and Criminal Investigations. Denttio, Inc.Accessed March 7, 2017. Retrieved from https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm543694.htm….

…FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (February 2017). Inspections, Compliance, Enforcement, and Criminal Investigations. Denttio, Inc.Accessed March 7, 2017. Retrieved from https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm543694.htm….

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Scott Gottlieb, FDA

President Trump to Pick Scott Gottlieb as FDA Commish

By MedTech Intelligence Staff

President Trump will reportedly nominate Scott Gottlieb, M.D. to serve as the next FDA commissioner. Gottlieb served as deputy commissioner for medical and scientific affairs during the George W. Bush…

President Trump will reportedly nominate Scott Gottlieb, M.D. to serve as the next FDA commissioner. Gottlieb served as deputy commissioner for medical and scientific affairs during the George W. Bush…

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Global Regulatory Strategy

Top Tips for Your Global Regulatory Strategy

By Maria Fontanazza

…regulatory affairs, Medtronic “The value of the regulatory strategy: Helping the commercial team have an understanding of what they can do and how to achieve it.” – Sergio Gadaleta, senior…

…regulatory affairs, Medtronic “The value of the regulatory strategy: Helping the commercial team have an understanding of what they can do and how to achieve it.” – Sergio Gadaleta, senior…

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Pol Van Dorpe, imec
Soapbox

DNA Sequencing Becoming Routine

By Pol Van Dorpe, Ph.D., Yves Moreau

…areas, whereas the large equipment is useful for producing complete genetic maps quickly and accurately. Chip technology is particularly important for making these systems more compact, faster and less expensive.”…

…areas, whereas the large equipment is useful for producing complete genetic maps quickly and accurately. Chip technology is particularly important for making these systems more compact, faster and less expensive.”…

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Matthew Hein, U.S. Department of Commerce

Should I Pursue Emerging Medtech Markets?

By MedTech Intelligence Staff

…those patient populations and the regulatory burdens more manageable, suggests Hein in the following video, which was filmed during the MedTech Intelligence Global Regulatory conference last week. https://www.youtube.com/watch?v=cSNS9fWitCg&feature=youtu.be    …

…those patient populations and the regulatory burdens more manageable, suggests Hein in the following video, which was filmed during the MedTech Intelligence Global Regulatory conference last week. https://www.youtube.com/watch?v=cSNS9fWitCg&feature=youtu.be    …

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Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Management Review, Be Careful of What You Share

By Dr. Christopher Joseph Devine

for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (December 2016). Inspections, Compliance, Enforcement, and Criminal Investigations. Nomax, Inc….

for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (December 2016). Inspections, Compliance, Enforcement, and Criminal Investigations. Nomax, Inc….

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