Webinar Information


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


ISO 13485:2016 Implementation and 2019 March Deadline – 2 hours Virtual Boot Camp, Denver, Colorado, United States
Webinar Title
ISO 13485:2016 Implementation and 2019 March Deadline – 2 hours Virtual Boot Camp
Event Type
Webinar
Webinar Date
17-05-2018
Last Date for Applying
17-05-2018
Location
Denver, Colorado, United States

Publish / Maintain / Marketing / Hosted By
Organization Name / Organize By
Training Doyens
Organizing/Related Departments
Training Doyens
Organization Type
Organization/Company
Webinar Category
Both (Technical & Non Technical)
Webinar Level
All (State/Province/Region, National & International)
Related Industries

Research/Science

Biotechnology

Medical/Healthcare/Hospital

OTHERS

Location
Denver, Colorado, United States

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

Others Details

Know how to address the gaps and manage transition activities, in addition to managing your certification audit for ISO 13485:2016.

Registration Fees
Available
Registration Fees Details
Live Session for one participant $229 Corporate Live Session Group – Max 10 Participants from one location. $579 Recorded Session Get unlimited access to audio recording of the webinar for 6 months. $249 Training DVD or USB Flash Drive Free shipment within 72 Hours, from the date of webinar completion $429 Super Combo Offer 1 Live and Recorded webinar $359 Super Combo Offer 2 Live and Training DVD / USB Flash Drive $529
Registration Ways
Email
Phone
Website
Other
Address/Venue
26468 E Walker Dr, Aurora, Colorado 80016  Pin/Zip Code : 80016
Landmark
CO
Official Email ID
support@trainingdoyens.com
Contact
Training Doyens

26468 E Walker Dr, Aurora, Colorado 80016

support@trainingdoyens.com

   8883008494
Michael smith

26468 E Walker Dr, Aurora, Colorado 80016

support@trainingdoyens.com

   8883008494    Fax No: Aurora