The Medical Devices Introductory Course 2020

Learning Objectives

• Described the available conformity assessment options and how to select the most appropriate one for your product(s) • Described the General Safety and Performance Requirements, the role of Harmonised Standards and Common Specifications

and the content of the Technical Documentation • Explained the process for getting the CE mark

HOWARD DOBBS

The Organisation for Professionals in Regulatory Affairs

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Which CA option would you choose for…

Class IRSI Class IMF Class IS Class IIa Class IIb Class III Class III Class III

Reusable surgical instrument

Sphygmomanometer

Sterile examination gloves

Sterile syringe

Bone screw

Biodegradable bone screw Condom with spermicide

Pacemaker

IVD Glucose monitor What if you had no design control or no QMS?

HOWARD DOBBS

The Organisation for Professionals in Regulatory Affairs

46