…of strength include the IPO market, with 43 companies going public in the 12-month period that ended June 30, and 16 mergers and acquisitions deals in excess of $1 billion….
…of strength include the IPO market, with 43 companies going public in the 12-month period that ended June 30, and 16 mergers and acquisitions deals in excess of $1 billion….
…is about the recognition that when a company has a good technology, it wants to deliver it to patients as quickly as possible without compromising safety and effectiveness. “We’re focused…
…is about the recognition that when a company has a good technology, it wants to deliver it to patients as quickly as possible without compromising safety and effectiveness. “We’re focused…
Blame it on the lack of ROI, the size of the market, or the complexity involved in product design. Or, is it the lack of incentive? Whatever the reasoning may…
Blame it on the lack of ROI, the size of the market, or the complexity involved in product design. Or, is it the lack of incentive? Whatever the reasoning may…
…compliance issue, the storage of a flammable liquid in the vicinity of finished goods (regardless of commodity) is a common sense issue, or should the doctor state the obvious and…
…compliance issue, the storage of a flammable liquid in the vicinity of finished goods (regardless of commodity) is a common sense issue, or should the doctor state the obvious and…
…to patient. Only 44% of medical device companies have a UDI strategy in place, according to a recent study. Pricing pressures Increasing competition by generic medical devices, combined with the…
…to patient. Only 44% of medical device companies have a UDI strategy in place, according to a recent study. Pricing pressures Increasing competition by generic medical devices, combined with the…
…Industry and FDA Reviewers. Retrieved from www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm070801.pdf References National Center for Education Statistics, The Health Literacy of America’s Adults: Results from the 2003 National Assessment of Adult Literacy. Retrieved from…
…Industry and FDA Reviewers. Retrieved from www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm070801.pdf References National Center for Education Statistics, The Health Literacy of America’s Adults: Results from the 2003 National Assessment of Adult Literacy. Retrieved from…
…in East Africa. The company is also one of four finalists in the MedTech Innovator 2015 Competition. Selected out of 300 companies, MobileODT and the other finalists had to demonstrate…
…in East Africa. The company is also one of four finalists in the MedTech Innovator 2015 Competition. Selected out of 300 companies, MobileODT and the other finalists had to demonstrate…
…management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (August 20, 2015). Inspections, Compliance, Enforcement, and Criminal Investigations, NCS Pearson. Accessed September 25, 2015. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm463351.htm…
…management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (August 20, 2015). Inspections, Compliance, Enforcement, and Criminal Investigations, NCS Pearson. Accessed September 25, 2015. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm463351.htm…
…save you time in the long run. The risk management documentation actually serves multiple purposes, including: Communicating to your product development team and company management the risks involved with the…
…save you time in the long run. The risk management documentation actually serves multiple purposes, including: Communicating to your product development team and company management the risks involved with the…
“Inherently, complaints are just information—they’re pieces of information that come to FDA; they’re pieces of information that come to you as manufacturers,” according to Carl Fischer, Ph.D., director, Division of…
“Inherently, complaints are just information—they’re pieces of information that come to FDA; they’re pieces of information that come to you as manufacturers,” according to Carl Fischer, Ph.D., director, Division of…
