…your organization with a little gem, a Form 483 with multiple inspectional observations. The good news is you do not have to respond to the 483. The bad news is…
…your organization with a little gem, a Form 483 with multiple inspectional observations. The good news is you do not have to respond to the 483. The bad news is…
…What device manufacturers need to do As stated in the previous section, the Seihin Hyojun Sho is not optional. The good news is that if a device manufacturer has previously…
…What device manufacturers need to do As stated in the previous section, the Seihin Hyojun Sho is not optional. The good news is that if a device manufacturer has previously…
…Projects in the Top Companies, McGraw-Hill. National Medal of Technology Winner Watts Humphrey (2010). 1927-2010 (Software Engineering Institute, Carnegie Mellon University, University News Items, October 28, 2010). Humphrey, W.S., Chick,…
…Projects in the Top Companies, McGraw-Hill. National Medal of Technology Winner Watts Humphrey (2010). 1927-2010 (Software Engineering Institute, Carnegie Mellon University, University News Items, October 28, 2010). Humphrey, W.S., Chick,…
…Japanese, the phrase is: “覆水盆に帰らず.” The literal translation is “Spilled water will not return to the tray” or simply stated, “No use crying over spilled milk.” The good news is…
…Japanese, the phrase is: “覆水盆に帰らず.” The literal translation is “Spilled water will not return to the tray” or simply stated, “No use crying over spilled milk.” The good news is…
…been through the process. An article written by Brian Dolan for mobihealthnews in May 2011 describes a panel that he moderated with several mobile health app companies who have already…
…been through the process. An article written by Brian Dolan for mobihealthnews in May 2011 describes a panel that he moderated with several mobile health app companies who have already…
…PMDA, it is probably part of a longer conversation about removing medical devices from the Japanese market that fail to meet safety and efficacy standards. The good news is, the…
…PMDA, it is probably part of a longer conversation about removing medical devices from the Japanese market that fail to meet safety and efficacy standards. The good news is, the…
…manufacturers. The good news is hiring Second Party Auditors (a.k.a. consultants like Dr. D) is an acceptable practice. The key is to ensure the Second Party Auditor is competent. Another…
…manufacturers. The good news is hiring Second Party Auditors (a.k.a. consultants like Dr. D) is an acceptable practice. The key is to ensure the Second Party Auditor is competent. Another…
…references: Many Hospitals Now Safely Reuse ‘Single-Use’ Medical Devices, by Kathryn Siranosian. Triple Pundit.com. March 12th, 2010 Sustainability Issues Looming for Designers, by Frank Esposito. Plastic News. April 25, 2011…
…references: Many Hospitals Now Safely Reuse ‘Single-Use’ Medical Devices, by Kathryn Siranosian. Triple Pundit.com. March 12th, 2010 Sustainability Issues Looming for Designers, by Frank Esposito. Plastic News. April 25, 2011…
…on-site assessment is probably going to be in order due to the significant increase in risk associated with finished medical device sterilization. The good news is that the purchasing process…
…on-site assessment is probably going to be in order due to the significant increase in risk associated with finished medical device sterilization. The good news is that the purchasing process…
…validation process is to ask another simple question. Was the correct device designed? The doctor is going to share some more earth-shattering news with the readers. You cannot arbitrarily make…
…validation process is to ask another simple question. Was the correct device designed? The doctor is going to share some more earth-shattering news with the readers. You cannot arbitrarily make…
