…new methods and tools. To help manage these challenges, medical device companies have found new ways to improve the product development process. These process improvements—and the challenges that drive them—are…
…new methods and tools. To help manage these challenges, medical device companies have found new ways to improve the product development process. These process improvements—and the challenges that drive them—are…
…managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (2014, November). FDA.gov Website. Retrieved November 19, 2014, http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm421235.htm…
…managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (2014, November). FDA.gov Website. Retrieved November 19, 2014, http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm421235.htm…
…is clearly the final goal. Without it, commercialization stalls. The following blog is the fourth in a series of posts that examines the relationship between reimbursement and regulatory approval. Last…
…is clearly the final goal. Without it, commercialization stalls. The following blog is the fourth in a series of posts that examines the relationship between reimbursement and regulatory approval. Last…
…to avoid any non-compliance issues. Going global All device manufacturers have to comply with the UDI mandate. Companies that do not comply with UDI guidelines may face a potential issue…
…to avoid any non-compliance issues. Going global All device manufacturers have to comply with the UDI mandate. Companies that do not comply with UDI guidelines may face a potential issue…
…the approach risk-based. For example, there should be a direct correlation between product and user risk back to critical components. People; remember not every component is going to be critical….
…the approach risk-based. For example, there should be a direct correlation between product and user risk back to critical components. People; remember not every component is going to be critical….
…managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (2014, November). FDA.gov Website. Retrieved November 19, 2014, http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm421235.htm…
…managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (2014, November). FDA.gov Website. Retrieved November 19, 2014, http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm421235.htm…
…is home to more than 7,000 medical device companies with estimated annual sales of $106 to $116 billion per year. The largest concentrations of companies are located in California, Massachusetts,…
…is home to more than 7,000 medical device companies with estimated annual sales of $106 to $116 billion per year. The largest concentrations of companies are located in California, Massachusetts,…
…generates an entire new skin surface in two to five weeks. Traditional stick-to-skin adhesives can result in hair pulling at removal, and skin stretches resulting in mechanical trauma and possible…
…generates an entire new skin surface in two to five weeks. Traditional stick-to-skin adhesives can result in hair pulling at removal, and skin stretches resulting in mechanical trauma and possible…
…is faster and less expensive, some hospitals substitute high level disinfection for sterilization of medical instruments. An article highlighting a comparison of sterilization techniques can be downloaded by clicking here….
…is faster and less expensive, some hospitals substitute high level disinfection for sterilization of medical instruments. An article highlighting a comparison of sterilization techniques can be downloaded by clicking here….
…managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (2014, November). FDA.gov Website. Retrieved November 10, 2014, http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm419624.htm…
…managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (2014, November). FDA.gov Website. Retrieved November 10, 2014, http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm419624.htm…
