…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…
…(that the competition can’t immediately claim) is destined to show modest results or none at all. Engage outside expertise to complement your core competencies. Understand your limits. An opportunity to…
…(that the competition can’t immediately claim) is destined to show modest results or none at all. Engage outside expertise to complement your core competencies. Understand your limits. An opportunity to…
…out and/or in another Community language acceptable to the notified body. 12. By way of derogation from paragraphs 1 to 4, the competent authorities may authorize, on duly justified request,…
…out and/or in another Community language acceptable to the notified body. 12. By way of derogation from paragraphs 1 to 4, the competent authorities may authorize, on duly justified request,…
…The Member State shall immediately inform the Commission of any such measures, indicating the reasons for its decision and, in particular, whether non-compliance with this Directive is due to: (a)…
…The Member State shall immediately inform the Commission of any such measures, indicating the reasons for its decision and, in particular, whether non-compliance with this Directive is due to: (a)…
…Article 7 – Committee on Medical Devices The Commission shall be assisted by the committee set up by Article 6(2) of Directive 90/385/EEC. The representative of the Commission shall submit…
…Article 7 – Committee on Medical Devices The Commission shall be assisted by the committee set up by Article 6(2) of Directive 90/385/EEC. The representative of the Commission shall submit…
…http://www.medicaldevices.org/node/212 2002/364/EC. (2002, May). Commission decision on 7 May 2002 on common technical specifications for in vitro-diagnostic medical devices. Retrieved November 8, 2011, from http://eur-lex.europa.eu 2009/108/EC. (2009, October). Commission Decision…
…http://www.medicaldevices.org/node/212 2002/364/EC. (2002, May). Commission decision on 7 May 2002 on common technical specifications for in vitro-diagnostic medical devices. Retrieved November 8, 2011, from http://eur-lex.europa.eu 2009/108/EC. (2009, October). Commission Decision…
…and the Commission, all medical devices shipped from the United States into the European Economic Community (EEC) can ship for free; henceforth the title, “Free Movement.” Ha, Ha, Ha, I…
…and the Commission, all medical devices shipped from the United States into the European Economic Community (EEC) can ship for free; henceforth the title, “Free Movement.” Ha, Ha, Ha, I…
…and guidance into complying with Article 4 (Free Movement) of the In Vitro Diagnostic Medical Device Directive, a.k.a., IVDD – cheers from Dr. D and best wishes for continued professional…
…and guidance into complying with Article 4 (Free Movement) of the In Vitro Diagnostic Medical Device Directive, a.k.a., IVDD – cheers from Dr. D and best wishes for continued professional…
…(ISO 13485:2003). Dr. D’s first book “Devine Guidance for Complying with the FDA’s Quality System Regulation” has finally been published. Visit http://devineguidanceinternational.com or Amazon to obtain a copy. (ISBN: 9781466358768)…
…(ISO 13485:2003). Dr. D’s first book “Devine Guidance for Complying with the FDA’s Quality System Regulation” has finally been published. Visit http://devineguidanceinternational.com or Amazon to obtain a copy. (ISBN: 9781466358768)…
…a great business opportunity. Embracing the push toward more sustainable practices now will give you and your company a competitive advantage by providing product differentiation and increasing profits. The ‘Big…
…a great business opportunity. Embracing the push toward more sustainable practices now will give you and your company a competitive advantage by providing product differentiation and increasing profits. The ‘Big…
