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MDR CONDITIONS, ETHICAL PRINCIPLES, METHODS, INFORMED CONSENT

$179.00

This lecture investigates the new Medical Device Regulation (MDR) with regard to conditions, ethical principles, methods and informed consent process. The intent of this tutorial is to describe the conditions for carrying out clinical investigations and to outline the rules laid down by MDR for particular clinical investigation types.

Description

Why take this course

This lecture investigates the new Medical Device Regulation (MDR) with regard to conditions, ethical principles, methods and informed consent process. The intent of this tutorial is to describe the conditions for carrying out clinical investigations and to outline the rules laid down by MDR for particular clinical investigation types.

What I will learn

This course will highlight each and every aspect you need to learn about the new Medical Decive Classification adopted by the European Parliament and Europeaon and discorver the different types of clinical investigations.

Skills I will gain

  • Discover the conditions for carrying out clinical investigations
  • Learn about the ethical principles, methods and informed consent process
  • Explore additional rules for clinical investigations related to incapacitated subjects, minors, pregnant and breastfeeding women and in emergency situations

 

TOPICS

  • Introduction (00:01:56)
  • Conditions for Conformity Assessment (00:04:08)
  • Informed Consent (00:03:44)
  • Additional Rules (00:06:42)
  • MDD vs MDR (00:02:54)
  • Conclusion (00:00:45)

  • Final Test – MDR Conditions, Ethical Principals, Methods, Informed Consent
  • Certification

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