Detail kurzu
MDR - Medical device regulation
DNV GL Business Assurance Czech Republic s.r.o.
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.
Hodnocení
Organizátor
DNV GL Business Assurance Czech Republic s.r.o.
Thákurova 4/531, Praha 6 Dejvice
Společnosti dnes působí v prostředí, kde se lidská selhání neodpouští. Vytváření ambiciózních cílů a strategií je jednoduché – obtížnější je jejich realizace prostřednictvím zaměstnanců. DNV GL nabízí odborné akreditované kurzy, které Vám pomohou v nekončícím procesu zvyšování kvalifikace Vašich zaměstnanců.
