Devine Guidance

Try Obtaining Clearance First, Dudes

By Dr. Christopher Joseph Devine

Seriously, a company decides to just start selling a medical device on the U. S. Market without obtaining FDA clearance in advance? Seriously, a company actually believes that they can…

Seriously, a company decides to just start selling a medical device on the U. S. Market without obtaining FDA clearance in advance? Seriously, a company actually believes that they can…

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MEDdesign

The Changing Healthcare Ecosystem and a “Systems Thinking” Approach

By Tim Bosch

…needed to create a complete solution–or to fix longstanding problems. This unconventional way of thinking often produces significantly different results than traditional approaches, especially for situations involving dynamic, complex flows…

…needed to create a complete solution–or to fix longstanding problems. This unconventional way of thinking often produces significantly different results than traditional approaches, especially for situations involving dynamic, complex flows…

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

You Can’t Outsource Your Quality and Regulatory Responsibilities

By Dr. Christopher Joseph Devine

…really enjoys the opportunities associated with providing consulting services to these new companies. In some cases, these new virtual organizations may be “acephalous” (look-it-up), with the collective powers of the…

…really enjoys the opportunities associated with providing consulting services to these new companies. In some cases, these new virtual organizations may be “acephalous” (look-it-up), with the collective powers of the…

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

Orange Jumps Suits – Try One On!

By Dr. Christopher Joseph Devine

…Criminal Investigations. (2011, November). FDA Website. Retrieved January 19, 2014, from http://www.fda.gov/iceci/criminalinvestigations/ucm280937.htm. Office of Criminal Investigations – the enforcement story. (2006). FDA Website. Retrieved January 19, 2014, from http://www.fda.gov/downloads/iceci/enforcementactions/enforcementstory/enforcementst oryarchive/ucm090866.pdf….

…Criminal Investigations. (2011, November). FDA Website. Retrieved January 19, 2014, from http://www.fda.gov/iceci/criminalinvestigations/ucm280937.htm. Office of Criminal Investigations – the enforcement story. (2006). FDA Website. Retrieved January 19, 2014, from http://www.fda.gov/downloads/iceci/enforcementactions/enforcementstory/enforcementst oryarchive/ucm090866.pdf….

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

FDA Inspection Readiness

By Dr. Christopher Joseph Devine

…is no such thing as minimum compliance or maximum compliance, there is just compliance. The best advice Dr. D can offer is to always be in a state of compliance…

…is no such thing as minimum compliance or maximum compliance, there is just compliance. The best advice Dr. D can offer is to always be in a state of compliance…

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MEDdesign

Anywhere, Everywhere Healthcare

…followed by a moderated brainstorm where the audience participates in answering the following questions: What are the key issues regarding the topic; What are the barriers to overcoming these issues…

…followed by a moderated brainstorm where the audience participates in answering the following questions: What are the key issues regarding the topic; What are the barriers to overcoming these issues…

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

Supplier Management – You Own It!

By Dr. Christopher Joseph Devine

…requirements. (a) Evaluation of suppliers, contractors, and consultants. Each manufacturer shall establish and maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants. Each manufacturer…

…requirements. (a) Evaluation of suppliers, contractors, and consultants. Each manufacturer shall establish and maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants. Each manufacturer…

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

Time for Reflection

By Dr. Christopher Joseph Devine

…quality and regulatory compliance, quality and regulatory compliance (Dr. D’s humble opinion) should win every single time. Why? Have fun trying to get FDA to review and approve new products…

…quality and regulatory compliance, quality and regulatory compliance (Dr. D’s humble opinion) should win every single time. Why? Have fun trying to get FDA to review and approve new products…

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MEDdesign

Stratos Case Study – Developing an “All-in-One” Medical Device

…of developing surgical products that are intuitive in design, improve patient outcomes and offer economic solutions for the surgeon and healthcare facility. The company is headquartered in Smithtown, New York….

…of developing surgical products that are intuitive in design, improve patient outcomes and offer economic solutions for the surgeon and healthcare facility. The company is headquartered in Smithtown, New York….

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