ISO 13485:2016 Medical Technological Products Understanding and Interpretation

Detailed Description

ISO 13485:2016 “Medical devices – Quality management systems – System requirements for regulatory purposes”, specifies the criteria for the quality management system to be implemented specifically by organizations operating in the medical device industry. The standard has recently been revised to meet the latest developments in quality management systems, technology and industry-related legislative requirements.

This program is addressed to executives of companies involved in the manufacture, import, marketing and distribution of medical technology products as well as to executives of health units, mainly in the supply and quality department. Also, to professionals in the field of consulting services, certification in the field of medical technological products as well as technical support and those responsible for drafting technical dossiers of medical technological products

Duration: 8 hours

What does the Training Program Provide ?

Purpose

• learning the purpose and scope of ISO 13485:2016.
• identifying key definitions and terminology to help you interpret and apply the requirements of ISO 13485:2016
• the analysis of the fundamental requirements of ISO 13485:2016 and how they relate to each other to form a strong and effective system
• how ISO 13485 relates to the new Medical Device Regulation (MDR)

What Is the Participation Procedure ?

• Contact us via e-mail at: tuvacademy@tuv.al
• Complete the application form
• Book your participation
• We will follow the whole process from start to finish.

Who Do I Contact for the Certification ?

Phone: +355 4 45 00 523/4

Email: tuvacademy@tuv.al