ComplianceOnline

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

Instructor: John Chapman
Product ID: 701003
  • Duration: 60 Min

recorded version

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Last Recorded Date: Apr-2014

Training CD

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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.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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