…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…
…It is up to the notified body to determine the statistical basis for which testing on product is to be performed. The good news is as the manufacturer you have…
…It is up to the notified body to determine the statistical basis for which testing on product is to be performed. The good news is as the manufacturer you have…
…stating compliance. If they fail, they receive a long laundry list of deviations that will require correction. The good news is that in any event, the notified body is required…
…stating compliance. If they fail, they receive a long laundry list of deviations that will require correction. The good news is that in any event, the notified body is required…
Article 21 (Amendment of Directives) of the IVDD (98/79/EC) delineates changes to Directives approved by the Commission. The good news is that although the Amendment of Directives is embedded…
Article 21 (Amendment of Directives) of the IVDD (98/79/EC) delineates changes to Directives approved by the Commission. The good news is that although the Amendment of Directives is embedded…
…are hurting or have the ability to hurt their citizens. Can you say the Member States do not want these devices entering their borders? The good news, for the device…
…are hurting or have the ability to hurt their citizens. Can you say the Member States do not want these devices entering their borders? The good news, for the device…
…device in question. The good news is, regardless of the opinion rendered by the Commission, the Directive requires them to inform Member States of their actions and publish the measures…
…device in question. The good news is, regardless of the opinion rendered by the Commission, the Directive requires them to inform Member States of their actions and publish the measures…
…Eudamed is no longer optional but obligatory. The good news is that the data entry requirement is a Competent Authority responsibility and not a device manufacturer. The bad news for…
…Eudamed is no longer optional but obligatory. The good news is that the data entry requirement is a Competent Authority responsibility and not a device manufacturer. The bad news for…
