…market for new products, thereby boosting revenues and market share. Inspired by the DOD’s research, this article discusses how to optimize a new product’s MRL by focusing on the prototyping…
…market for new products, thereby boosting revenues and market share. Inspired by the DOD’s research, this article discusses how to optimize a new product’s MRL by focusing on the prototyping…
…in the development process or avoided all together. Often, developers perform back-filling activities to ensure a complete design history file, but they’re doing the work, such as conducting user research…
…in the development process or avoided all together. Often, developers perform back-filling activities to ensure a complete design history file, but they’re doing the work, such as conducting user research…
…of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA (May 2015). Inspections, Compliance, Enforcement, and Criminal Investigations. AG Industries, Warning Letter. Accessed June…
…of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA (May 2015). Inspections, Compliance, Enforcement, and Criminal Investigations. AG Industries, Warning Letter. Accessed June…
…comes to managing the development and documentation process with a comprehensive software platform, there can be even more barriers to achieving a streamlined process. As devices become more complex, it’s…
…comes to managing the development and documentation process with a comprehensive software platform, there can be even more barriers to achieving a streamlined process. As devices become more complex, it’s…
In recognition of the evolving landscape in the medical device industry and the need to provide a designed-in strategy to customers, 3M Medical Specialties has relaunched with the new name…
In recognition of the evolving landscape in the medical device industry and the need to provide a designed-in strategy to customers, 3M Medical Specialties has relaunched with the new name…
When a medical device recall is initiated, whether a correction or removal, questions often arise related to supplier responsibility. Roberta Goode, president of Goode Compliance International, discusses the concerns that…
When a medical device recall is initiated, whether a correction or removal, questions often arise related to supplier responsibility. Roberta Goode, president of Goode Compliance International, discusses the concerns that…
A new generation of wearable medical devices, miniaturized “lab-on-a-chip” diagnostic tests and other life-enhancing innovations are being made possible, in part, through the use of technologies provided by the newly-relaunched…
A new generation of wearable medical devices, miniaturized “lab-on-a-chip” diagnostic tests and other life-enhancing innovations are being made possible, in part, through the use of technologies provided by the newly-relaunched…
…delivered for introduction into interstate commerce for commercial distribution this device with major changes or modifications to the intended use without submitting a new premarket notification to FDA as required…
…delivered for introduction into interstate commerce for commercial distribution this device with major changes or modifications to the intended use without submitting a new premarket notification to FDA as required…
…device companies looking to enter or expand into the lucrative Chinese market. Although the Chinese government and companies have made an effort to improve IP protection in recent years, China…
…device companies looking to enter or expand into the lucrative Chinese market. Although the Chinese government and companies have made an effort to improve IP protection in recent years, China…
…experts will be discussing how to find common ground at the Combination Products conference June 24-25, in Washington, DC. Register now. * The BCC Research report references drug-device combinations only…
…experts will be discussing how to find common ground at the Combination Products conference June 24-25, in Washington, DC. Register now. * The BCC Research report references drug-device combinations only…
