Understanding ISO 13485 vs. ISO 9001 for Successful QMS in Medical Device Industries

This presentation will help you to understand ISO 13485 and implement a successful quality management system, comparing it to ISO 9001 and FDA & European Union requirements.

Description

ISO 13485:2003 is a quality management system standard specially written for the medical device industry and is on the U S Food & Drug Administration (FDA) list of recognized consensus standards. Medical device firms certified to ISO 13485:2003 will find themselves very closely compliant with FDA’s Quality System Requirements under 21CFR 820. This presentation will help you to understand ISO 13485 and implement a successful quality management system, comparing it to ISO 9001 and FDA & European Union requirements.

Areas Covered in the webinar:

• Principles of ISO 13485:2003.
• ISO 9001 & ISO 13485 Differences.
• Risk Management & ISO 14971.
• FDA’s MDR’s & EU Vigilance.
• Design Control.
• MDD 93/42/EEC & Essential Requirements.

Who will benefit:

Companies interested in understanding and implementing a quality management system that is universally accepted by regulatory authorities.Employees who will benefit include:

• Quality & Regulatory Professionals
• Quality System Auditors
• Manufacturing & Design Engineers
• Marketing Product Managers

Instructor Profile:

John Chapman,, BS, MBA, RAC has over 30 years medical device regulatory experience and over 10 years experience with the European Union’s medical device directive, 93/42/EEC. John has led two device companies to ISO quality system certification and CE marking. He has been performed regulatory due diligence on over a dozen acquisitions in the past 12 years, exposing him to numerous quality systems, including consent decrees as well as many notified bodies. He earned his regulatory affairs certification (RAC) in 1998 and was a contributing author to 2004 Fundamentals of EU Regulatory Affairs, RAPS, 2004. He co-founded a local RAPS chapter and has been a speaker at these meetings and the annual RAPS conference.