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

Temperature and Humidity Count, Who Knew?

By Dr. Christopher Joseph Devine

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

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

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FDA

FDAā€™s UDI Draft Guidance Aims to Help with Rule Compliance

By MedTech Intelligence Staff

FDA just released a draft guidance to assist with compliance with the Unique Device Identifier (UDI) rule. The UDI rule requires that most medical device labels and packages have a…

FDA just released a draft guidance to assist with compliance with the Unique Device Identifier (UDI) rule. The UDI rule requires that most medical device labels and packages have a…

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Soapbox

Personalized Medicine a Megatrend

By Klaus Jopp

companies require suppliers to deliver more lightweight yet powerful components, modules and chips, or dedicated energy and data storage systems. As the number of people developing chronic diseases continues to…

companies require suppliers to deliver more lightweight yet powerful components, modules and chips, or dedicated energy and data storage systems. As the number of people developing chronic diseases continues to…

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

Consent Decree, Oh My!

By Dr. Christopher Joseph Devine

…820 Compliance. Charleston, SC: Amazon. FDA. (February 2016). Consent Decree of Permanent Injunction entered in United States v. Custom Ultrasonics, Inc. Accessed. July 15, 2016. Retrieved from http://www.fda.gov/downloads/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cdrh/cdrhfoiaelectronicreadingroom/ucm487452.pdf    …

…820 Compliance. Charleston, SC: Amazon. FDA. (February 2016). Consent Decree of Permanent Injunction entered in United States v. Custom Ultrasonics, Inc. Accessed. July 15, 2016. Retrieved from http://www.fda.gov/downloads/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cdrh/cdrhfoiaelectronicreadingroom/ucm487452.pdf    …

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MedTech Intelligence

Most Popular MedTech Articles

By MedTech Intelligence Staff

MedTech Intelligence has compiled a list of the most-read articles over the past few months. 5. Failure of Management with Executive Responsibility Dr. D catches another rarely cited Form 483…

MedTech Intelligence has compiled a list of the most-read articles over the past few months. 5. Failure of Management with Executive Responsibility Dr. D catches another rarely cited Form 483…

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Ameing for Asia

Quality Matters: Do It Right the First Time

By Ames Gross

…wrong regulatory consulting company. There is a severe shortage of efficient and competent Japanese RA executives. For example, a few weeks ago a U.S. medtech company contacted me about its…

…wrong regulatory consulting company. There is a severe shortage of efficient and competent Japanese RA executives. For example, a few weeks ago a U.S. medtech company contacted me about its…

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Checkbox

Eight Things You Need to Know about Unique Device Identification

By Steve Cottrell, Madris Tomes

…response. If the FDA later denies the exemption request, that labeler will have to act fast to comply with UDI compliance deadlines—and UDI compliance is not a process that companies…

…response. If the FDA later denies the exemption request, that labeler will have to act fast to comply with UDI compliance deadlines—and UDI compliance is not a process that companies…

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Michael Lau, director of human factors, Insight Product Development
MEDdesign

The Value of a Sound Human Factors Plan

By Michael Lau, Ph.D.

…provides a compelling business case for why companies cannot afford to overlook human factors. Consider instead the many other positive outcomes that are derived from creating products that have been…

…provides a compelling business case for why companies cannot afford to overlook human factors. Consider instead the many other positive outcomes that are derived from creating products that have been…

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

You Didnā€™t Document Compliance? Then It Didnā€™t Happen

By Dr. Christopher Joseph Devine

…management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (June 2016). Inspections, Compliance, Enforcement, and Criminal Investigations. General Medical Company. Accessed July 11, 2016. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm508251.htm…

…management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (June 2016). Inspections, Compliance, Enforcement, and Criminal Investigations. General Medical Company. Accessed July 11, 2016. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm508251.htm…

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Ellyn McMullin, Axendia
Soapbox

Next Steps in FDAā€™s Global Transformation

By Ellyn McMullin

Five years ago FDA unveiled its new global strategy to help ensure safety and quality of imported products in an increasingly complex global supply chain. According to the agency, in…

Five years ago FDA unveiled its new global strategy to help ensure safety and quality of imported products in an increasingly complex global supply chain. According to the agency, in…

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