…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…
…device into the European market. The good news is that unlike your Tom-Tom or similar GPS devices that require ongoing updates to ensure the maps are current, the IVDD does…
…device into the European market. The good news is that unlike your Tom-Tom or similar GPS devices that require ongoing updates to ensure the maps are current, the IVDD does…
…an end in sight? The bad news is that device manufactures have run out of label space and IFUs have turned into books. The good news is print on-demand is…
…an end in sight? The bad news is that device manufactures have run out of label space and IFUs have turned into books. The good news is print on-demand is…
…carried out) pursuant to this Directive or any provision of national law putting it into effect. What you need to know The good news is that device manufacturers only need…
…carried out) pursuant to this Directive or any provision of national law putting it into effect. What you need to know The good news is that device manufacturers only need…
…II. The good news is that for device manufacturers that already comply with EN ISO 13485:2003, compliance with Annex II, from a quality system standpoint, is a proverbial “cake walk.”…
…II. The good news is that for device manufacturers that already comply with EN ISO 13485:2003, compliance with Annex II, from a quality system standpoint, is a proverbial “cake walk.”…
