De norm rond verpakkingsmateriaal EN ISO 11607 - Wat is belangrijk?

Dit artikel is gebaseerd op een presentatie gegeven tijdens een seminar voor deskundigen centrale sterilisatie , georganiseerd in Wolfheze op 22 oktober 2009 door Kimberly-Clark.

Geschreven door Mireille De Cré , Pharm. D., MDCPartners (Chair CEN/TC205, Expert CEN/CLC/TC3, CEN TC 102, ISO TC198, Eucomed STF, ABHS)

Click here to read the article (in Dutch - translations to follow)

On the 13th September 2009 the RAPS Annual Conference & Exhibition will kick off at the Pennsylvania Convention Center in Philadelphia, USA. In its tradition MDCPartners will be present.

Mireille De Cre, Pharm., Senior Partner, has received the honour of providing a talk in one of the afternoon sessions on the 15th September on the case study: Identifying Premarket Medical Device Issues from 3:30-5:00pm.

Her talk is titled A Closer Look at Standards for Medical Devices and will address the increasing role that standards (design, testing, labeling) are playing as de facto requirements for global premarket submissions, and why regulatory professionals need to understand more about this increasingly critical area. The discussion will include a look at how emerging developments and trends are shaping medical device regulation.

For more information, please go to www.raps.org or contact MDCPartners at +32 3 870 97 50.