Medical device recall

Recall Readiness: Combating Recall Fatigue

By Maria Fontanazza

…establishing a comprehensive and up-to-date recall plan well in advance can be one of the most effective ways to combat recall fatigue. The plan should address all the different aspects…

…establishing a comprehensive and up-to-date recall plan well in advance can be one of the most effective ways to combat recall fatigue. The plan should address all the different aspects…

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Top 10

Top 10 Business Requirements for Combination Products

By Alberto Velez

combination product’s business risk compare to normal project’s business risk (return on investments, net present values, etc.). Ensure the senior management has visibility to the market potential, competitive landscape, regulatory…

combination product’s business risk compare to normal project’s business risk (return on investments, net present values, etc.). Ensure the senior management has visibility to the market potential, competitive landscape, regulatory…

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

Trick or Treat: Warning Letters

By Dr. Christopher Joseph Devine

…– 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (August 2016). Inspections, Compliance, Enforcement, and Criminal Investigations. Spiegelberg Gmbh & Co. KG. Accessed October 31, 2016. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm515340.htm…

…– 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (August 2016). Inspections, Compliance, Enforcement, and Criminal Investigations. Spiegelberg Gmbh & Co. KG. Accessed October 31, 2016. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm515340.htm…

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Medtech, innovation

Keeping Patients in Mind: Demand for Digitization

By Dr. Lutz Retzlaff

…providing good medical care in rural communities could boost technological improvements. Ulrike Röhr, Vice-President of the LandFrauenVerband Schleswig-Holstein (Country Women’s Association of Schleswig-Holstein), will use the MEDICA HEALTH IT FORUM…

…providing good medical care in rural communities could boost technological improvements. Ulrike Röhr, Vice-President of the LandFrauenVerband Schleswig-Holstein (Country Women’s Association of Schleswig-Holstein), will use the MEDICA HEALTH IT FORUM…

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American Flag

MedTech and the 2016 Election: Who Wins?

By Maria Fontanazza

…Clinton’s campaign has not commented on one of the biggest issues brought on by the ACA that is affecting medical device companies: The 2.5% medical device excise tax, which was…

…Clinton’s campaign has not commented on one of the biggest issues brought on by the ACA that is affecting medical device companies: The 2.5% medical device excise tax, which was…

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Boston Scientific

Boston Scientific Hits $2.1 Billion in Q3 Sales

By MedTech Intelligence Staff

…11% increase compared to the prior year period. According to a company release, Boston Scientific reported the following growth: Business Units MedSurg: 15% Cardiovascular: 13% Rhythm Management: 4% Geographies United…

…11% increase compared to the prior year period. According to a company release, Boston Scientific reported the following growth: Business Units MedSurg: 15% Cardiovascular: 13% Rhythm Management: 4% Geographies United…

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Medtronic

Medtronic Wins FDA Approval for Largest TAVR System in United States

By MedTech Intelligence Staff

Today Medtronic announced FDA approval of its CoreValve Evolut, the largest transcatheter aortic valve replacement (TAVR) available in the United States. The R 34-mm valve is indicated to treat severe…

Today Medtronic announced FDA approval of its CoreValve Evolut, the largest transcatheter aortic valve replacement (TAVR) available in the United States. The R 34-mm valve is indicated to treat severe…

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FDA Launches Website to Report Regulatory Misconduct

By MedTech Intelligence Staff

Today the FDA has announced the establishment of a website through which anyone can report an allegation of regulatory misconduct. Examples of allegations include promoting or advertising a device outside…

Today the FDA has announced the establishment of a website through which anyone can report an allegation of regulatory misconduct. Examples of allegations include promoting or advertising a device outside…

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UPS Distribution Center, Medtech

Make Your Supply Chain Smarter

By Maria Fontanazza

Risk in the supply chain is an ongoing issue for many global medical device companies. The pressures of cost and regulatory compliance, among other factors, can be difficult to manage…

Risk in the supply chain is an ongoing issue for many global medical device companies. The pressures of cost and regulatory compliance, among other factors, can be difficult to manage…

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