…Authority will come calling. Once that dreaded call is received from the Competent Authority, the device manufacturer must withdraw all products with the wrongly-affixed CE Mark ASAP! Until the next…
…Authority will come calling. Once that dreaded call is received from the Competent Authority, the device manufacturer must withdraw all products with the wrongly-affixed CE Mark ASAP! Until the next…
…satisfy everyone, because our personalities and emotions vary. Some people are open to new things while others are more conservative; some people are energetic while some are lazy. For some…
…satisfy everyone, because our personalities and emotions vary. Some people are open to new things while others are more conservative; some people are energetic while some are lazy. For some…
…device is marketed in, compliance with the IVDD, MDD, AIMDD, QSR, CMDCAS, TGA, etc. (enough acronyms for today) is not optional. Compliance to the laws regulating medical devices is mandatory….
…device is marketed in, compliance with the IVDD, MDD, AIMDD, QSR, CMDCAS, TGA, etc. (enough acronyms for today) is not optional. Compliance to the laws regulating medical devices is mandatory….
…authorized representative established in the Community, shall lay down, by common accord, the time limits for completion of the assessment and verification operations referred to in Annexes III to VII….
…authorized representative established in the Community, shall lay down, by common accord, the time limits for completion of the assessment and verification operations referred to in Annexes III to VII….
…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…
…for its decision. The Commission shall consult the interested parties and the Member States and, where the national measures are justified, adopt necessary Community measures. Those measures, designed to amend…
…for its decision. The Commission shall consult the interested parties and the Member States and, where the national measures are justified, adopt necessary Community measures. Those measures, designed to amend…
…consumer products companies will drive success for their businesses. Two forces are driving medical devices to become more like consumer products: patient use and physician expectations. Companies who deliver great…
…consumer products companies will drive success for their businesses. Two forces are driving medical devices to become more like consumer products: patient use and physician expectations. Companies who deliver great…
…with domain knowledge about the problem. Degree of structure: Some ideations methods provide more guidelines and/or processes. Research has shown that individuals new to group ideation perform better using more…
…with domain knowledge about the problem. Degree of structure: Some ideations methods provide more guidelines and/or processes. Research has shown that individuals new to group ideation perform better using more…
HAPPY NEW YEAR! Dr. D would like to welcome the readers back from the Holiday break and hope each of you had a great start to the New Year. Speaking…
HAPPY NEW YEAR! Dr. D would like to welcome the readers back from the Holiday break and hope each of you had a great start to the New Year. Speaking…
…required to note the term “New” on any notification when a device is new to the EU. Who knew? The Competent Authorities will retain the right, for a two-year period,…
…required to note the term “New” on any notification when a device is new to the EU. Who knew? The Competent Authorities will retain the right, for a two-year period,…
