…169 and provides guidance on sustaining compliance and successfully navigating audits from the Pharmaceuticals and Medical Devices Agency (PMDA), you will quickly realize the similarities when compared to EN ISO…
…169 and provides guidance on sustaining compliance and successfully navigating audits from the Pharmaceuticals and Medical Devices Agency (PMDA), you will quickly realize the similarities when compared to EN ISO…
…Product data sheets are available at www.dymax.com. One simple but effective method to monitor if the curing has gone to completion is incorporated into the 1201-M-SC product. This material uses…
…Product data sheets are available at www.dymax.com. One simple but effective method to monitor if the curing has gone to completion is incorporated into the 1201-M-SC product. This material uses…
…in Japan. (2012). Emergo Group Website. Retrieved June 10, 2012, from http://www.slideshare.net/emergogroup Will you let slip the world 2nd largest medical device market? (2010). Retrieved June 8, 2012, from http://www.asiaitc.com/download…
…in Japan. (2012). Emergo Group Website. Retrieved June 10, 2012, from http://www.slideshare.net/emergogroup Will you let slip the world 2nd largest medical device market? (2010). Retrieved June 8, 2012, from http://www.asiaitc.com/download…
…mantra, “Just Comply, Baby!” Dr. D really struggled on how to wrap-up and place a pretty bow on this series about understanding and complying with the IVDD. Since it really…
…mantra, “Just Comply, Baby!” Dr. D really struggled on how to wrap-up and place a pretty bow on this series about understanding and complying with the IVDD. Since it really…
…the anatomical foot/ankle joint of able-bodied runners…” (http://www.ossur.com/?PageID=13462). It works great, even if it looks like a bent spoon made of carbon fiber. Fig.3: Bespoke Innovations Inc.’s Scan.Design.Print 3D Technology…
…the anatomical foot/ankle joint of able-bodied runners…” (http://www.ossur.com/?PageID=13462). It works great, even if it looks like a bent spoon made of carbon fiber. Fig.3: Bespoke Innovations Inc.’s Scan.Design.Print 3D Technology…
…condition of validity of delivered certificates. What IVDD medical device manufacturers need to know As previously stated in the introduction, compliance with Annex IV of the IVDD commences with the…
…condition of validity of delivered certificates. What IVDD medical device manufacturers need to know As previously stated in the introduction, compliance with Annex IV of the IVDD commences with the…
…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…
…much easier than a one-sentence Article. There is no Euro-legalese, associated regulatory jargon or infinite do-loops, just a simple statement of compliance. The doctor often sees the failure to meet…
…much easier than a one-sentence Article. There is no Euro-legalese, associated regulatory jargon or infinite do-loops, just a simple statement of compliance. The doctor often sees the failure to meet…
…University. Prescott Valley, AZ. Devine, C. (2011). Devine Guidance series on complying with the MDD. Published in The Medical Device Summit. http://medicaldevicesummit.com Directive 98/79/EC. (1998, October). Directive 98/79/EC of the…
…University. Prescott Valley, AZ. Devine, C. (2011). Devine Guidance series on complying with the MDD. Published in The Medical Device Summit. http://medicaldevicesummit.com Directive 98/79/EC. (1998, October). Directive 98/79/EC of the…
