…has noticed that the FDA warning letter page has been relatively boring when it comes to medical device manufacturers and associated violations of the ACT (Food, Drug, and Cosmetic Act)….
…has noticed that the FDA warning letter page has been relatively boring when it comes to medical device manufacturers and associated violations of the ACT (Food, Drug, and Cosmetic Act)….
…the Draft Guidance when preparing your approach to comply with the Stability Testing requirements. Comment 23 of the combination products CGMP addresses the role of reserve samples as important in…
…the Draft Guidance when preparing your approach to comply with the Stability Testing requirements. Comment 23 of the combination products CGMP addresses the role of reserve samples as important in…
…include dental labs and hearing aid companies. Now, 3-D printed products have grown to include: Medical equipment and surgical tools Prosthetic limbs and casts Bones and cartilage Organs and blood…
…include dental labs and hearing aid companies. Now, 3-D printed products have grown to include: Medical equipment and surgical tools Prosthetic limbs and casts Bones and cartilage Organs and blood…
…decision-making Modernize biocompatibility and biological risk evaluation of device materials\ Leverage real-world evidence and use evidence synthesis across multiple domains in regulatory decision-making Advance tests and methods for predicting and…
…decision-making Modernize biocompatibility and biological risk evaluation of device materials\ Leverage real-world evidence and use evidence synthesis across multiple domains in regulatory decision-making Advance tests and methods for predicting and…
Where do the acceptance criteria for process validations come from? Even though this is one of the most important aspects of the validation process, the answer to this question is…
Where do the acceptance criteria for process validations come from? Even though this is one of the most important aspects of the validation process, the answer to this question is…
Johnson & Johnson is reportedly acquiring Abbott Medical for $4.3 billion. The cash transaction is part of the company’s strategy to grow its vision care business. We’ve been actively and…
Johnson & Johnson is reportedly acquiring Abbott Medical for $4.3 billion. The cash transaction is part of the company’s strategy to grow its vision care business. We’ve been actively and…
…health care companies have sustainability programs within their own operations that track energy, waste and water use, but these same companies may be just starting in their efforts to more…
…health care companies have sustainability programs within their own operations that track energy, waste and water use, but these same companies may be just starting in their efforts to more…
…Devine, C. (2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (September 2016). Inspections, Compliance, Enforcement,…
…Devine, C. (2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (September 2016). Inspections, Compliance, Enforcement,…
…treating patients with complex PAD,” said John Laird, M.D., interventional cardiologist at U.C. Davis Medical Center and co-principal investigator for the IN.PACT SFA Trial, in a Medtronic press release. “Until…
…treating patients with complex PAD,” said John Laird, M.D., interventional cardiologist at U.C. Davis Medical Center and co-principal investigator for the IN.PACT SFA Trial, in a Medtronic press release. “Until…
The Medical Device Single Audit Program (MDSAP) is transitioning to full implementation by January 1, 2017. In anticipation, FDA has set up 10 medical device education modules to help companies…
The Medical Device Single Audit Program (MDSAP) is transitioning to full implementation by January 1, 2017. In anticipation, FDA has set up 10 medical device education modules to help companies…
