Yesterday the National Capital Consortium for Pediatric Device Innovation (NCC-PDI) Competition gave a quarter of a million dollars to six companies that are developing products to address unmet pediatric needs….
Yesterday the National Capital Consortium for Pediatric Device Innovation (NCC-PDI) Competition gave a quarter of a million dollars to six companies that are developing products to address unmet pediatric needs….
…of issues, from patient, clinical and engineering perspectives to evaluating and integrating risk management into various functions within a company. During an interactive panel, Jon Speer, founder & VP QA/RA…
…of issues, from patient, clinical and engineering perspectives to evaluating and integrating risk management into various functions within a company. During an interactive panel, Jon Speer, founder & VP QA/RA…
…common understanding of where and how the end product is being used. Of course this is much easier to preach than to actually put into practice. So where can companies…
…common understanding of where and how the end product is being used. Of course this is much easier to preach than to actually put into practice. So where can companies…
Last week the Senate confirmed the appointment of Robert Califf, M.D., as the next FDA commissioner. The 89-4 vote, however, was not without outspoken opposition—and the most vocal opponents were…
Last week the Senate confirmed the appointment of Robert Califf, M.D., as the next FDA commissioner. The 89-4 vote, however, was not without outspoken opposition—and the most vocal opponents were…
…system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (September 30, 2015). Inspections, Compliance, Enforcement, and Criminal Investigations. Merge Healthcare, Inc. Accessed February 23, 2016. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm466204.htm…
…system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (September 30, 2015). Inspections, Compliance, Enforcement, and Criminal Investigations. Merge Healthcare, Inc. Accessed February 23, 2016. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm466204.htm…
…than causes of a quality problem, much like first aid. These actions do nothing to address root causes or prevent reoccurrence of the quality problem. A few examples of common…
…than causes of a quality problem, much like first aid. These actions do nothing to address root causes or prevent reoccurrence of the quality problem. A few examples of common…
…helping governments, companies and healthcare practitioners in Asia meet growing demand for medical devices to help manage infectious diseases. While the market is increasingly competitive, the range of devices available…
…helping governments, companies and healthcare practitioners in Asia meet growing demand for medical devices to help manage infectious diseases. While the market is increasingly competitive, the range of devices available…
…semi-constrained with a cemented acetabular component and the hip joint metal/metal semi-constrained with an uncemented acetabular component. “FDA believes that there is insufficient evidence and information to conclude that general…
…semi-constrained with a cemented acetabular component and the hip joint metal/metal semi-constrained with an uncemented acetabular component. “FDA believes that there is insufficient evidence and information to conclude that general…
…key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (December 9, 2015). Inspections, Compliance, Enforcement, and Criminal Investigations. LAR MFG., LLC….
…key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (December 9, 2015). Inspections, Compliance, Enforcement, and Criminal Investigations. LAR MFG., LLC….
Establishing risk acceptability is a fundamental yet complex part of risk management, throughout the product lifecycle. With a variety of factors involved in the process, medical device companies face the…
Establishing risk acceptability is a fundamental yet complex part of risk management, throughout the product lifecycle. With a variety of factors involved in the process, medical device companies face the…
