Detail kurzu

Popis kurzu

  • The medical device directive (MDD) has been in force since

    1996 and it is mandatory to comply with it to CE mark products

    in the EU.

  • There has been an amendment in 20017 (2007/47/EC) and today

    there are new regulation on their way to replace the directive

    = MDR.

  • The new regulation is based on theMDD, the guidance documents to

    the MDD (MEDDEV)and also new and changed parts are coming.

Obsah kurzu

  • To give a good introduction of the MDR as preparation of what is

    coming soon.

  • What kind of requirements will increased, changed and what

    preparation is neccessary for transition and need to be start

    as soon as possible.

Cílová skupina

  • Management,design and development engineers, QA/RA specialists,

    risk managers, custoooomers support/service, clinical support,

    marketing, contract manufacturer and component manufacturer as

    applicable.

Certifikát TK355 - ISO 13485, ISO 14971 and IEC 62366

Kontaktní osoba

Sylva Hefnerová
+420 233 321 231
sylva.hefnerova@dnvgl.com

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