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Ref : 28985
Event :ISO 14971:2012 - Does your current Risk Analysis still comply with your CE Mark requirements?

Date :Tuesday April 02nd, 2019

Location :Palo Alto
2479 East Bayshore Road,
Suite 200
94303 Palo Alto, United States

Type :Conference & Seminar - International audience

Accreditation :--


Further information


This webinar will benefit medical device companies planning to have a CE mark under the European Union Directive 93/42/EEC. We will discuss what is new in ISO 14971:2012 and help you avoid delays in obtaining or maintaining your CE mark for compliance to the Medical device Directive, EU Directive 93/42/EEC on Medical Devices.


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) CE Mark
  • Knowing what you have to do to update your Risk Analysis for continued MDD Compliance
  • How to update your Risk Management process to ensure continued MDD compliance


Areas Covered in this Webinar:

  • 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


Betty Lane

Betty Lane
Founder and President, Be Quality Associates LLC

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 for both FDA and ISO 13485 compliance band business when they became FDA and industry requirements. Her are areas of expertise include training, auditing, supplier management, design controls including risk management, software validation and general safety.

Betty’s training experience includes over 25 years of training on all areas ISO 13485 and FDA cGMP, in companies where she worked as manager or director, and for AAMI, ASQ biomedical division, and ASQ sections. She has taught courses in medical quality and regulatory affairs as an Adjunct 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 RAPS, 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, and an MBA from Northeastern University.


Map and directions
Conference address :
Palo Alto
2479 East Bayshore Road,
Suite 200
94303 Palo Alto
United States
tel : +1-888-717-2436
Map and directions

Further information

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ISO 14971:2012 - Does your current Risk Analysis still comply with your CE Mark requirements? Management - Hospital
iso 14971:2012 compliance, medical device risk analysis, ce mark requirements, medical device risk management procedure, medical device directive, eu mdd, ce mark, medical device risk management
Professionals, This webinar will provide valuable assistance to: Medical Device Quality Management Medical Device Regulatory Affairs Medical Device Quality Engineers Medical Device Design Engineers Compliance managers Quality auditors in medical device companies
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