Course Description

Overview of the Medical Device Design and Development Process

Course Description:

This course is an overview of the basic elements of a well defined and controlled design process starting with the sources of requirements for design including state of the art requirements, design output processes, design verification and transfers and design change control.

Learning Objectives:

Upon completion of this course, trainees will be able to correctly and successfully:

  • Identify the many steps involved in a well controlled and documented design process.
  • Communicate in a more efficient manner with the engineering groups with an understanding of what documentation processes are involved.

Who Should Enroll:

Professionals new to the medical device industry, whether inventors, managers, CEO’s or business professionals in need to understand the elements of the CE-mark process.

Prerequisite Knowledge/Requirements:

Understand the CE-mark process including the essential requirements from the MDD and/or AIMD, risk management process and other important steps to CE-mark.

Subject Matter Expert:
Petros Kanellos

77 min

Related resources:

Case studies:

Basic Account: € 227.00
Premium Account: € 171.00

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