…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…
…Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (September 9, 2015). Inspections, Compliance, Enforcement, and Criminal…
…Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (September 9, 2015). Inspections, Compliance, Enforcement, and Criminal…
…the move to cloud-based solutions can be scary. Companies continue to house stacks upon stacks of paper documentation for a variety of reasons—concern of data security, compatibility of cloud-based solutions…
…the move to cloud-based solutions can be scary. Companies continue to house stacks upon stacks of paper documentation for a variety of reasons—concern of data security, compatibility of cloud-based solutions…
…As a result, more Western device companies are coming back to Japan. This makes it all the more crucial for these companies to take the right steps to understand the…
…As a result, more Western device companies are coming back to Japan. This makes it all the more crucial for these companies to take the right steps to understand the…
…the company. Once adopted, open innovation causes organizational boundaries to become permeable and encourage the combining of company resources with external resources. Figure 1. Open Innovation involves the sharing of…
…the company. Once adopted, open innovation causes organizational boundaries to become permeable and encourage the combining of company resources with external resources. Figure 1. Open Innovation involves the sharing of…
