…added. Complaint handling is added as a completely new sub-clause to the standard. The requirement to report to the appropriate authorities is also expanded. Products Status identification of product is…
…added. Complaint handling is added as a completely new sub-clause to the standard. The requirement to report to the appropriate authorities is also expanded. Products Status identification of product is…
A look at some common mistakes medical device companies make when approaching risk….
A look at some common mistakes medical device companies make when approaching risk….
…2016. Retrieved from http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM488020.pdf FDA. (February 2016). Regulatory History. Accessed February 2, 2016. Retrieved from http://www.fda.gov/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/essurepermanentbirthcontrol/ucm452270.htm FDA. (February 2016). Essure Permanent Birth Control. Accessed February 2, 2016. Retrieved from http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/EssurePermanentBirthControl/default.htm…
…2016. Retrieved from http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM488020.pdf FDA. (February 2016). Regulatory History. Accessed February 2, 2016. Retrieved from http://www.fda.gov/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/essurepermanentbirthcontrol/ucm452270.htm FDA. (February 2016). Essure Permanent Birth Control. Accessed February 2, 2016. Retrieved from http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/EssurePermanentBirthControl/default.htm…
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…
…of protecting public health while encouraging innovation and the introduction of new life-saving therapies to the market… Dr. Califf’s life in medicine and research has positively impacted the lives of…
…of protecting public health while encouraging innovation and the introduction of new life-saving therapies to the market… Dr. Califf’s life in medicine and research has positively impacted the lives of…
…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…
…are funneling investment into infectious disease research. As a result, regional hospitals, clinicians, and research centers are increasingly demanding more sophisticated medical devices to detect and manage preventable diseases such…
…are funneling investment into infectious disease research. As a result, regional hospitals, clinicians, and research centers are increasingly demanding more sophisticated medical devices to detect and manage preventable diseases such…
