…lot of money.” With last-minute surprises bound to arise, companies must pull together all critical departments, from regulatory and quality to marketing, legal, clinical and finance in order to prepare….
…lot of money.” With last-minute surprises bound to arise, companies must pull together all critical departments, from regulatory and quality to marketing, legal, clinical and finance in order to prepare….
…management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (March 2016). Inspections, Compliance, Enforcement, and Criminal Investigations. Grams Medical, Inc. Accessed May 4, 2016. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm497792.htm…
…management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (March 2016). Inspections, Compliance, Enforcement, and Criminal Investigations. Grams Medical, Inc. Accessed May 4, 2016. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm497792.htm…
Quality systems at medical device and diagnostic companies are based on well documented standard operating procedures (SOPs) that are efficiently communicated to employees. Introducing SOPs and ensuring that they are…
Quality systems at medical device and diagnostic companies are based on well documented standard operating procedures (SOPs) that are efficiently communicated to employees. Introducing SOPs and ensuring that they are…
…for many decades and know well what they can do to improve their security posture. At the other end of spectrum, there are [companies], for example, new entrants into the…
…for many decades and know well what they can do to improve their security posture. At the other end of spectrum, there are [companies], for example, new entrants into the…
The development of low-cost, high-quality smartphones is changing the way that patients and doctors communicate with one another. This new trend is the result of medical device companies teaming up…
The development of low-cost, high-quality smartphones is changing the way that patients and doctors communicate with one another. This new trend is the result of medical device companies teaming up…
…as a mechanism by which the Agency can share initial thoughts regarding emerging technologies that are likely to be of public health importance early in product development.” Comments can be…
…as a mechanism by which the Agency can share initial thoughts regarding emerging technologies that are likely to be of public health importance early in product development.” Comments can be…
…using STAR technology (yet the researchers said that this is comparable to the average time to complete laparoscopic anastomosis at 30 to 90 minutes). According to Peter Kim, vice president…
…using STAR technology (yet the researchers said that this is comparable to the average time to complete laparoscopic anastomosis at 30 to 90 minutes). According to Peter Kim, vice president…
…when the device itself is compromised, but the device could also be used as a conduit into the hospital’s network and put the hospital’s network at risk for compromise by…
…when the device itself is compromised, but the device could also be used as a conduit into the hospital’s network and put the hospital’s network at risk for compromise by…
…for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (March 2016). Inspections, Compliance, Enforcement, and Criminal Investigations. Grams Medical,…
…for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (March 2016). Inspections, Compliance, Enforcement, and Criminal Investigations. Grams Medical,…
Yesterday FDA released information about a voluntary recall of Cook Medical’s catheters with Beacon Tip technology. On April 15, the company recalled 4,146,309 catheters that were found to exhibit degradation…
Yesterday FDA released information about a voluntary recall of Cook Medical’s catheters with Beacon Tip technology. On April 15, the company recalled 4,146,309 catheters that were found to exhibit degradation…
