Laura Johnson, Loftware

5 Labeling Trends Affecting MedTech

By Laura Johnson

…necessary training and support. References Pettey, C. (2016). “Innovate Under Every Condition: The Bimodal Supply Chain,” Retrieved from http://www.gartner.com/smarterwithgartner/innovate-under-every-condition-the-bimodal-supply-chain/ Gartner IT Glossary. Retrieved from http://www.gartner.com/it-glossary/bimodal/. The annual survey referenced in…

…necessary training and support. References Pettey, C. (2016). “Innovate Under Every Condition: The Bimodal Supply Chain,” Retrieved from http://www.gartner.com/smarterwithgartner/innovate-under-every-condition-the-bimodal-supply-chain/ Gartner IT Glossary. Retrieved from http://www.gartner.com/it-glossary/bimodal/. The annual survey referenced in…

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

Refuse Facility Access to FDA and Bad Things Happen

By Dr. Christopher Joseph Devine

…the act. Compliance for Dummies For this week’s guidance the compliance for dummies will be really brief. Comply baby, just comply! Seriously, if a foreign establishment wishes to enter a…

…the act. Compliance for Dummies For this week’s guidance the compliance for dummies will be really brief. Comply baby, just comply! Seriously, if a foreign establishment wishes to enter a…

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Dollar, money

Integra LifeSciences to Acquire J&Jā€™s Codman Neurosurgery

By MedTech Intelligence Staff

…Integra anticipates that if J&J accepts the binding offer it will become a leader in neurosurgical devices, as its portfolio will complement Integra’s line of products for tissue ablation, dural…

…Integra anticipates that if J&J accepts the binding offer it will become a leader in neurosurgical devices, as its portfolio will complement Integra’s line of products for tissue ablation, dural…

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Medical device recall

High Fracture Rate: Zimmer Biomet Recalls Reverse Shoulder

By MedTech Intelligence Staff

Today FDA released an announcement that Zimmer Biomet is recalling its Comprehensive Reverse Shoulder due to a high fracture rate. This device issue can lead to adverse events, including permanent…

Today FDA released an announcement that Zimmer Biomet is recalling its Comprehensive Reverse Shoulder due to a high fracture rate. This device issue can lead to adverse events, including permanent…

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Heart

Was Device Tax Responsible for 29k Job Loss?

By MedTech Intelligence Staff

The medical device tax went into effect in 2013, but its impact was felt even earlier, as device companies prepared for the 2.3% excise tax via widespread layoffs. And although…

The medical device tax went into effect in 2013, but its impact was felt even earlier, as device companies prepared for the 2.3% excise tax via widespread layoffs. And although…

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Footsteps

Remediation: Risk Priorities

By Maria Fontanazza

…widespread in the standards community, and certainly, there are many types of risk. However, the different risks being considered and addressed by various stakeholders can create regulatory problems if it…

…widespread in the standards community, and certainly, there are many types of risk. However, the different risks being considered and addressed by various stakeholders can create regulatory problems if it…

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Allergan

Allergan to Buy Zeltiq Aesthetics for Nearly $2.5 Billion

By MedTech Intelligence Staff

Today Allergan announced its intention to acquire California-based medical aesthetics company Zeltiq Aesthetics, Inc. Zeltiq manufactures products that use its patented cooling technology, most notably the CoolSculpting System, which is…

Today Allergan announced its intention to acquire California-based medical aesthetics company Zeltiq Aesthetics, Inc. Zeltiq manufactures products that use its patented cooling technology, most notably the CoolSculpting System, which is…

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

Misbranded Lap Bands & Prison, What a Tale!

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. (January 2017). 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. (January 2017). Inspections, Compliance, Enforcement, and Criminal Investigations….

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Footsteps

Remediation: Considerations During the Process

By Maria Fontanazza

…the fundamental considerations during remediation. MedTech Intelligence: What key points should device companies consider during remediation? Mark Leimbeck: Infrastructure If your company needs to generate information for legacy devices, you…

…the fundamental considerations during remediation. MedTech Intelligence: What key points should device companies consider during remediation? Mark Leimbeck: Infrastructure If your company needs to generate information for legacy devices, you…

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