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

…treating patients with complex PAD,” said John Laird, M.D., interventional cardiologist at U.C. Davis Medical Center and co-principal investigator for the IN.PACT SFA Trial, in a Medtronic press release. “Until…

…treating patients with complex PAD,” said John Laird, M.D., interventional cardiologist at U.C. Davis Medical Center and co-principal investigator for the IN.PACT SFA Trial, in a Medtronic press release. “Until…

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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 ā€œThe Fewer Steps the Betterā€

By Charlotte Lux, Ed Geiselhart

…success through adoption and loyalty. Defining it is also usually more complex than most people might think. The surest way of effectively managing this complexity is to adopt a user-centered…

…success through adoption and loyalty. Defining it is also usually more complex than most people might think. The surest way of effectively managing this complexity is to adopt a user-centered…

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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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Medical device recall

Cook Medical Recalls Wire Guides Due to Potential Glass in Hydrophilic Coating

By MedTech Intelligence Staff

Recalls and other field actions are an unavoidable part of the medical device industry. Join MedTech Intelligence for MEDICAL DEVICE RECALLS: Procedures & Best Practices | November 14–15 in Boston,…

Recalls and other field actions are an unavoidable part of the medical device industry. Join MedTech Intelligence for MEDICAL DEVICE RECALLS: Procedures & Best Practices | November 14–15 in Boston,…

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Product Development, Human factors engineering

HFE Practice Models: How Manufacturers Establish and Maintain HFE Competency

By Allison Strochlic, Michael Wiklund

UL’s human factors engineering (HFE) team has provided HFE support to more than 100 medical device and combination product manufacturers. In some cases, we have augmented a manufacturer’s internal capacity,…

UL’s human factors engineering (HFE) team has provided HFE support to more than 100 medical device and combination product manufacturers. In some cases, we have augmented a manufacturer’s internal capacity,…

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Barcode, UDI

Preparing for UDI in Europe

By Steve Cottrell, Madris Tomes

…changes to comply with UDI’s compliance date in 2014.2 Non-Compliance Ramifications Manufacturers that do not adopt UDI should be aware of the severe consequences of not meeting compliance standards. The…

…changes to comply with UDI’s compliance date in 2014.2 Non-Compliance Ramifications Manufacturers that do not adopt UDI should be aware of the severe consequences of not meeting compliance standards. The…

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