…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…
…optional. The good news is that the requirements do in fact mirror EN ISO 13485:2003. If your organization’s notified body has approved your QMS and issued a certificate stating the…
…optional. The good news is that the requirements do in fact mirror EN ISO 13485:2003. If your organization’s notified body has approved your QMS and issued a certificate stating the…
…these processes, which includes the supplier performing these processes. Surprise folks, this should not be earth-shattering news. An effective QMS is needed to support the manufacture of medical devices. Who…
…these processes, which includes the supplier performing these processes. Surprise folks, this should not be earth-shattering news. An effective QMS is needed to support the manufacture of medical devices. Who…
…– there are significant similarities between MO 169 and EN ISO 13485:2003; and that is very good news. Two – there is a mandatory examination requirement associated with the QMS….
…– there are significant similarities between MO 169 and EN ISO 13485:2003; and that is very good news. Two – there is a mandatory examination requirement associated with the QMS….
…(upon request) for a period of five years, after the end of the performance evaluation. The good news is that Dr. D believes the concepts associated with Annex VIII are…
…(upon request) for a period of five years, after the end of the performance evaluation. The good news is that Dr. D believes the concepts associated with Annex VIII are…
