ISO 14971:2012 - Does your current Risk Analysis still comply with your CE Mark requirements

Duration: 60 Minutes
This presentation will provide information on how to review your current risk analysis to make sure you fully comply with the requirements for Risk Analysis under EU Directive 93/42/EEC on Medical Devices and the other European Medical Device directives. The stricter interpretations will be expected during ISO 13485 audits and Technical File and Design Dossier document review starting in 2013. You cannot depend that you can meet these requirements just because your current risk analysis meets ISO14971:2007, unless you are fully aware of the implications of ISO14971:2012.
Medical Device Risk Management
Instructor: Betty Lane
Product ID: 500350

You may have heard that there are no new requirements in ISO 14971:2012, Medical devices - Application of risk management to medical devices, and that is true. However, the new informative annexes provided describe the relationship between complying with the requirements of ISO 14971 and the stricter requirements of the European medical device directives. This session will focus on those requirements for compliance to the MDD, EU Directive 93/42/EEC on Medical Devices, but will also cover how to comply with stricter requirements related to AIMDD, IVDD directives as well.

Why Should you Attend:
If you have or plan to have a CE mark under European Union Directive 93/42/EEC on Medical Devices (MDD) or other European Medical Device directives you must be aware of what is new in ISO 14971:2012 or you could face delays in obtaining or maintain your CE mark for compliance to the Medical Device Directives. This webinar will provide valuable assistance in:
  • Understanding what is new in ISO 1497:2012, Medical devices. Application of risk management to medical device
  • Understanding how ISO 1497:2012 impacts your Medical Device Directive (MDD, IVDD, AIMDD) CE Mark
  • Knowing what you have to do to update your Risk Analysis for continued European Medical Device Directives Compliance
  • How to update your Risk Management process to ensure continued European directive compliance and a valid CE mark
Objectives of the Presentation:
Understand:
  • What is ISO 14971
  • How ISO 1497:2012 differs from ISO 14971:2007
  • How to update your Risk Analysis to meet continued compliance to the European Medical Device Directive(MDD)
  • How to make sure your Risk Management procedure assures you can meet your CE mark requirements for Risk Analysis
Who can Benefit:
This webinar will provide valuable assistance to all personnel in:
  • Quality Management
  • Regulatory Affairs
  • Quality Engineers
  • Design Engineers
  • Compliance managers
  • Quality auditors
Live Session - How it works
  • Username and Password will be sent to you 24 hours prior to the webinar
  • Presentation handouts in pdf formate will be mailed to you
  • Login to the session using the username and password provided to you
  • Get answer to your queries through interactive Q&A sessions via chat
  • Please let us know your thoughts and views at the end of webinar, your valuable feedback will help us improve
  • Get certification of attendance.
Recorded Session - How it works
  • A link will be provided to you upon purchase of the recorded session
  • Please click on the link to access the session
  • Presentation handouts in pdf formate will be mailed to you
  • Get certification of attendance.
$375
Recorded Session for one participant
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How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Betty Lane has over 30 years’ experience in Medical Device quality assurance and regulatory affairs. She is the founder and President of Be Quality Associates, LLC, a consulting company helping small and medium sized medical device and diagnostic companies implement and improve their quality systems. Her work enables companies to manage their business in compliance with FDA and ISO 13485 requirements, as well quality system requirements for other area such as Europe and Canada. Her background in digital systems engineering enables her to facilitate design controls and software validation. Her areas of expertise include training, auditing, supplier management, document and records management, design controls, and software validation.

Betty’s training experience includes over 25 years of training on all areas ISO 13485 and FDA cGMP, in companies, and for AAMI, ASQ biomedical division, and ASQ sections. She has taught courses in medical quality and regulatory affairs at Northeastern University, Boston, MA. Betty is active in her local section of the American Society for Quality and is also a member of the Association for the Advancement of Medical Instrumentation (AAMI), The Society of Women Engineers and the IEEE. Betty has degrees in engineering from Rensselaer Polytechnic Institute (RPI), and an MBA from Northeastern University.
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