Folks, if an event or activity is not documented in writing, it never happened in the eyes of our friends at FDA. When it comes to retaining accurate records reflecting…
Folks, if an event or activity is not documented in writing, it never happened in the eyes of our friends at FDA. When it comes to retaining accurate records reflecting…
“Connected Health is the coming together of technology, devices, and people to enable increased access, improved care, lower costs and better outcomes.” – Montana Cherney, Connected Health – The User-Driven…
“Connected Health is the coming together of technology, devices, and people to enable increased access, improved care, lower costs and better outcomes.” – Montana Cherney, Connected Health – The User-Driven…
…Form 483 Observations for failing to comply with §820.181 (Device Master Record). In some cases, the failure to comply with §820.181 is finding its way into warning letters, a nice…
…Form 483 Observations for failing to comply with §820.181 (Device Master Record). In some cases, the failure to comply with §820.181 is finding its way into warning letters, a nice…
…regulatory and physician acceptance issues are sorted out. And me? I’ve just ordered the uChek kit at the introductory price of $20. References: http://www.wired.com/business/2013/02/smartphone-becomes-smart-lab/ http://www.geekosystem.com/new-iphone-pee-tester-app/ http://uchek.in/index.html http://www.cnn.com/2012/09/28/opinion/mahmud-mobile-medic http://www.healio.com/infectious-disease/emerging-diseases/news/print/infectious-disease-news/%7Bc49b830e-33ba-467d-b066-94ce4c7a0f0c%7D/texts-improved-malaria-treatment-adherence-among-hcws-in-kenya http://healthmarketinnovations.org/program/medicallhome http://www.wired.com/business/2013/02/smartphone-becomes-smart-lab/…
…regulatory and physician acceptance issues are sorted out. And me? I’ve just ordered the uChek kit at the introductory price of $20. References: http://www.wired.com/business/2013/02/smartphone-becomes-smart-lab/ http://www.geekosystem.com/new-iphone-pee-tester-app/ http://uchek.in/index.html http://www.cnn.com/2012/09/28/opinion/mahmud-mobile-medic http://www.healio.com/infectious-disease/emerging-diseases/news/print/infectious-disease-news/%7Bc49b830e-33ba-467d-b066-94ce4c7a0f0c%7D/texts-improved-malaria-treatment-adherence-among-hcws-in-kenya http://healthmarketinnovations.org/program/medicallhome http://www.wired.com/business/2013/02/smartphone-becomes-smart-lab/…
…going to share some of the more egregious comments and findings coming from notified body audits in 2013. Failure to comply with harmonized standards. Folks, there is no requirements to…
…going to share some of the more egregious comments and findings coming from notified body audits in 2013. Failure to comply with harmonized standards. Folks, there is no requirements to…
…technology is fully understood. Arguably, when developing a novel technology, the latter approach can have considerable advantages. Design for Commercialization: The excitement of commercializing a product, compounded by the desire…
…technology is fully understood. Arguably, when developing a novel technology, the latter approach can have considerable advantages. Design for Commercialization: The excitement of commercializing a product, compounded by the desire…
…Website. Retrieved April 20, 2013, from http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDASIA/ucm20027187.htm. Medical device establishment registration and listing – notice of changes for FY 2013. (2012, August). FDA Website. Retrieved April 20, 2013, from http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm314844.htm. …
…Website. Retrieved April 20, 2013, from http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDASIA/ucm20027187.htm. Medical device establishment registration and listing – notice of changes for FY 2013. (2012, August). FDA Website. Retrieved April 20, 2013, from http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm314844.htm. …
…complete them and complete them on time. In closing, thank you again for joining Dr. D and I hope you find value in the guidance provided. Until the next installment…
…complete them and complete them on time. In closing, thank you again for joining Dr. D and I hope you find value in the guidance provided. Until the next installment…
…13485 Certificates; Lead Auditor Certificate; Resume, etc., are acceptable in lieu of survey. • Standard Catalog Component Manufacturers • Low-Risk Components • Distributors of Catalog Components • Consultants • Facility…
…13485 Certificates; Lead Auditor Certificate; Resume, etc., are acceptable in lieu of survey. • Standard Catalog Component Manufacturers • Low-Risk Components • Distributors of Catalog Components • Consultants • Facility…
…their organizational woes. Sorry folks, but injecting the CAPA programs with steroids isn’t the answer. In fact, the more complex the CAPA system, the more opportunities for Dr. D’s good…
…their organizational woes. Sorry folks, but injecting the CAPA programs with steroids isn’t the answer. In fact, the more complex the CAPA system, the more opportunities for Dr. D’s good…
