The U.S. Food and Drug Administration (FDA) announced new actions to enhance the safety of reusable medical devices and address the possible spread of infectious agents between uses. The new…
The U.S. Food and Drug Administration (FDA) announced new actions to enhance the safety of reusable medical devices and address the possible spread of infectious agents between uses. The new…
…or needed additional engineering support. We were working together as one team.” For more information on UL’s services to support certification and global regulatory approvals, email Medical.Inquiry@ul.com or visit www.ul.com/medical….
…or needed additional engineering support. We were working together as one team.” For more information on UL’s services to support certification and global regulatory approvals, email Medical.Inquiry@ul.com or visit www.ul.com/medical….
An increasing number of Western device companies have been acquiring or entering into joint ventures with Asian medical firms. Acquisitions and joint ventures with Asian medical companies can provide many…
An increasing number of Western device companies have been acquiring or entering into joint ventures with Asian medical firms. Acquisitions and joint ventures with Asian medical companies can provide many…
…by their trade names instead of considering them collectively as a commodity. Additionally payers have imposed a very high evidence requirement consisting of randomized trials comparing the allografts either to…
…by their trade names instead of considering them collectively as a commodity. Additionally payers have imposed a very high evidence requirement consisting of randomized trials comparing the allografts either to…
…invaluable in a device establishment’s quest for commercialization of a new medical device. For example, if a device manufacturer is confident that their product is going to be a Class…
…invaluable in a device establishment’s quest for commercialization of a new medical device. For example, if a device manufacturer is confident that their product is going to be a Class…
…industries and product categories. The authors advise companies to build a group of executive champions within the engineering, quality, operations, and procurement units. Some medical-device companies, for example, already have…
…industries and product categories. The authors advise companies to build a group of executive champions within the engineering, quality, operations, and procurement units. Some medical-device companies, for example, already have…
…managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (2015, February). FDA.gov Website. Retrieved March1, 2015, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm433248.htm….
…managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (2015, February). FDA.gov Website. Retrieved March1, 2015, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm433248.htm….
…whether the action corrected the underlying problem partially, completely, or not at all. For example, if a software development team is repeatedly discovering defects after their application is released to…
…whether the action corrected the underlying problem partially, completely, or not at all. For example, if a software development team is repeatedly discovering defects after their application is released to…
…evenly between cardiology and endovascular products,” with about 70 percent coming from outside the U.S., according to a press release. Cardinal CEO George Barrett said the company may make more…
…evenly between cardiology and endovascular products,” with about 70 percent coming from outside the U.S., according to a press release. Cardinal CEO George Barrett said the company may make more…
…savvy entrepreneurs in the medical field ought to take notice of. Take the ride-sharing service Uber, for example. This company has taken the struggling, often unloved taxi industry and reinvented…
…savvy entrepreneurs in the medical field ought to take notice of. Take the ride-sharing service Uber, for example. This company has taken the struggling, often unloved taxi industry and reinvented…
