ISO 13485/13488 Medical Industry (EN 46001/2)

Basic Quality Requirements for the Medical Device Industry

The Basic Quality Requirements for the Medical Device Industry is a half-day course designed to provide participants will an introduction to the quality standards written for the medical device industry. Participants will identify which aspects of their quality system are not in compliance with the standards. Key success factors in managing the transition will also be discussed.

Who Should Attend?

The course is designed for executives and professionals who desire a basic understanding of the requirements
of the quality standards developed for the medical device industry.

Key Topics

Introduction

• What are the quality standards? QSR, ISO 9000, EN46001, CE Mark

Why do companies comply with the standards?

• Competitive and market place advantages/requirements
• Internal benefits

What do the standards require beyond the GMPs?

• QSR
• ISO 9001
• EN 46001
• CE Mark

What is the process of becoming registered to a standard?

• Steps to registration

What is required for an efficient implementation of a quality system which will result in permanent business benefits?

• Key success factors

Course Duration

This is a half day course and can be held at your site or at a venue close to your site. Please call us for a no-obligation, no-cost quote at 877-415-0191.

Thank you for your interest in BQPM Training!

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