FDA

CDRH Releases FY 2017 Regulatory Priorities

By MedTech Intelligence Staff

…monitoring clinical performance of medical devices Develop methods and tools to improve and streamline clinical trial design Develop computational modeling technologies to support regulatory decision-making Enhance the performance of digital…

…monitoring clinical performance of medical devices Develop methods and tools to improve and streamline clinical trial design Develop computational modeling technologies to support regulatory decision-making Enhance the performance of digital…

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Acceptance criteria, formula

Deriving Validation Acceptance Criteria

By William Brown

…factor results in a different confidence statement. For example, the confidence statement for a combination of sample size and k resulting in a probability of acceptance of 5% for a…

…factor results in a different confidence statement. For example, the confidence statement for a combination of sample size and k resulting in a probability of acceptance of 5% for a…

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Dollar, money

J&J Buys Abbott Medical for $4.3 Billion

By MedTech Intelligence Staff

Johnson & Johnson is reportedly acquiring Abbott Medical for $4.3 billion. The cash transaction is part of the company’s strategy to grow its vision care business. We’ve been actively and…

Johnson & Johnson is reportedly acquiring Abbott Medical for $4.3 billion. The cash transaction is part of the company’s strategy to grow its vision care business. We’ve been actively and…

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Ann Meitz, 3M

Sustainability in Product Design a Responsibility

By Maria Fontanazza

…health care companies have sustainability programs within their own operations that track energy, waste and water use, but these same companies may be just starting in their efforts to more…

…health care companies have sustainability programs within their own operations that track energy, waste and water use, but these same companies may be just starting in their efforts to more…

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

Double Vision

By Dr. Christopher Joseph Devine

…Devine, C. (2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (September 2016). Inspections, Compliance, Enforcement,…

…Devine, C. (2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (September 2016). Inspections, Compliance, Enforcement,…

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Medtronic

Medtronic Wins First FDA Approval for Drug-Coated Balloon for ISR

By MedTech Intelligence Staff

…device, the IN.PACT Admiral drug-coated balloon, will provide a new treatment option for PAD patients. The device received the CE Mark in 2009. “We are experiencing a paradigm shift in…

…device, the IN.PACT Admiral drug-coated balloon, will provide a new treatment option for PAD patients. The device received the CE Mark in 2009. “We are experiencing a paradigm shift in…

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FDA

Medical Device Single Audit Program: FDA Wants You

By MedTech Intelligence Staff

The Medical Device Single Audit Program (MDSAP) is transitioning to full implementation by January 1, 2017. In anticipation, FDA has set up 10 medical device education modules to help companies…

The Medical Device Single Audit Program (MDSAP) is transitioning to full implementation by January 1, 2017. In anticipation, FDA has set up 10 medical device education modules to help companies…

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User-centered design

Challenging the Assumption of “The Fewer Steps the Better”

By Charlotte Lux, Ed Geiselhart

…developers hold the conviction that fewer steps are better based on market research or voice of the customer (VOC) data: For example, a patient on a self-administered therapy declares, “I…

…developers hold the conviction that fewer steps are better based on market research or voice of the customer (VOC) data: For example, a patient on a self-administered therapy declares, “I…

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

FDA and DOJ Working Together: No If, Ands, or Butts: Part Deux

By Dr. Christopher Joseph Devine

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

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

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Ameing for Asia

Tissue Bank Market in Asia: 2016 Status

By Ames Gross

…success selling their products in Asia, with limited competition from domestic tissue banks. Examples include: Geistlich. A Swiss company that specializes in the production and sales of animal-based biomaterials for

…success selling their products in Asia, with limited competition from domestic tissue banks. Examples include: Geistlich. A Swiss company that specializes in the production and sales of animal-based biomaterials for

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