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Réf : 27194
Evènement :ISO 13485:2016 Implementation and 2019 March Deadline – 2 hours Virtual Boot Camp

Date :Jeudi 17 Mai 2018

Lieu :En ligne (Internet, Visioconférence, ...)

Type :Conférence & Séminaire - Audience Internationale

Accréditation :--


 

Informations

 

OVERVIEW

This 2-hour session will provide the attendees with experience gained in providing transition assistance to medical device companies over the last 2 years. Attendance includes examples of how to address the gaps most often observed and practical advice for managing transition activities as well as managing your certification audit for ISO 13485:2016.

WHY SHOULD YOU ATTEND

All organizations that are part of the medical device supply chain are required to establish a quality management system that conforms to ISO 13485. The transition period is coming to an end for the third edition of the standard and certifications to the second edition will expire by March 2019. If you haven’t completed the transition your organization may not be able to market devices in 2019 or you may have corrective actions forced on you by your customers. This webinar will provide you with practical actions you can take to ensure your certification to this new edition of the standard is obtained.

AREAS COVERED

  • Role of the organization
  • Risk-based approach
  • QMS Software validation requirements
  • Management Responsibilities (review)
  • Competence/Awareness of personnel
  • Updates to product realization including risk management
  • Updates to production/service
  • Post-market surveillance (Feedback/Complaint handling)

LEARNING OBJECTIVES

The Transition Period is coming to an end soon (February 2019). What are the key changes that require attention? Based on experience with transition, what areas are generally the biggest gap and what action should you take to ensure certification is obtain/maintained going into 2019?

WHO WILL BENEFIT

  • SMEs doing the work
  • Quality assurance
  • Regulatory Professionals
  • Biostatistics
  • Data Management

 

For more detail please click on this below link:

https://bit.ly/2vXVPOF

 

Email: support@trainingdoyens.com

Toll Free: +1-888-300-8494

Tel: +1-720-996-1616

Fax: +1-888-909-1882


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Annonceur

Training Doyens
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ISO 13485:2016 Implementation and 2019 March Deadline – 2 hours Virtual Boot Camp Pharmacie
iso 13485, iso 13485 changes, iso 13485 medical devices
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