…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, and…
…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, and…
…easily adjusted in a way that would be much harder if most design activities were completed before testing. Faced with a completed device that the user needs to engage with…
…easily adjusted in a way that would be much harder if most design activities were completed before testing. Faced with a completed device that the user needs to engage with…
This Saturday, October 8, the winners of the fourth annual Pediatric Surgical Innovation Symposium competition will be announced. Why is this important? Well, it’s no secret that the pediatrics market…
This Saturday, October 8, the winners of the fourth annual Pediatric Surgical Innovation Symposium competition will be announced. Why is this important? Well, it’s no secret that the pediatrics market…
…nutshell will be comprised of a combination of advanced software, sensors and communication technology. Machines on the shop floor will be connected to wired and wireless networks via embedded sensors…
…nutshell will be comprised of a combination of advanced software, sensors and communication technology. Machines on the shop floor will be connected to wired and wireless networks via embedded sensors…
…Unfortunately, it is easy come and easy go when it comes to her money. The Feds will be taking it all away, and some, with potential fines in excess of…
…Unfortunately, it is easy come and easy go when it comes to her money. The Feds will be taking it all away, and some, with potential fines in excess of…
…compliance of their combination products business. The following six combination product requirements should have good quantitative measures for this five-year plan. Delivery Packaging/Labeling codes and the expected order fill rate….
…compliance of their combination products business. The following six combination product requirements should have good quantitative measures for this five-year plan. Delivery Packaging/Labeling codes and the expected order fill rate….
…vessels Skin and human tissue Drugs Patient-specific orthopedic implants and comfortable customized prosthetics are among the most common 3-D printed medical products. Other 3-D printed products, particularly bioprinted organs and…
…vessels Skin and human tissue Drugs Patient-specific orthopedic implants and comfortable customized prosthetics are among the most common 3-D printed medical products. Other 3-D printed products, particularly bioprinted organs and…
…monitoring clinical performance of medical devices Develop methods and tools to improve and streamline clinical trial design Develop computational modeling technologies to support regulatory decision-making Enhance the performance of digital…
…monitoring clinical performance of medical devices Develop methods and tools to improve and streamline clinical trial design Develop computational modeling technologies to support regulatory decision-making Enhance the performance of digital…
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…
