chevron_left Categories

Other related webinars

FDA Compliant Practices for Medical Device Repor...

Friday, 20th April, 2012
Time : 02:00 PM EST | 11:00 AM PST

Current Good Manufacturing Practice for Medical ...

Friday, 25th May, 2012
Time : 02:00 PM EST | 11:00 AM PST

Medical Device Regulations in EU and CE-Marking

Friday, 15th June, 2012
Time : 02:00 PM EST | 11:00 AM PST

Best Practices for A Medical Device Complaint Ha...

Friday, 3rd August, 2012
Time : 02:00 PM EST | 11:00 AM PST

ISO 14971, Risk Management for Medical Devices

Friday, 2nd November, 2012
Time : 02:00 PM EST | 11:00 AM PST

FDA Medical Device Regulation : Overview of Com...

Friday, 26th April, 2013
Time : 01:00 PM EST | 10:00 AM PST

FDA Medical Device Warning Letter Trends and Pre...

Thursday, 17th April, 2014
Time : 01:00 PM EDT | 10:00 AM PDT

FDA requirements for Medical Devices and practic...

Friday, 11th July, 2014
Time : 01:00 PM | 10:00AM

Global Medical Device Standards State-of-the-Art...

Friday, 24th October, 2014
Time : 01:00 PM EST | 10:00 AM PST

Global Medical Device Risk Management - Demystif...

Friday, 6th March, 2015
Time : 01:00 PM EST | 10:00 AM PST

FDA Medical Device Regulation – An Introductio...

Friday, 15th May, 2015
Time : 02:00 PM EST | 11:00 AM PST

Recent EU Medical Device Regulatory Evolutions: ...

Friday, 16th October, 2015
Time : 01:00 PM EDT | 10:00 AM PDT

What you need to know about the CDRH’s Pre-sub...

Friday, 8th April, 2016
Time : 02:00PM EDT | 11:00 AM PDT

What you need to know about FDA's de novo Proces...

Friday, 13th May, 2016
Time : 02:00 PM EDT | 11:00 AM PDT

What you need to know about FDA’s Premarket Re...

Tuesday, 28th June, 2016
Time : 11:00 AM EST | 08:00 AM PST

Keys to Planning and Implementing a Medical Devi...

Wednesday, 28th September, 2016
Time : 01:00 PM EDT | 10:00 AM PDT

Process Validation Principles and Protocols for ...

Friday, 30th September, 2016
Time : 01:00 PM EDT | 10:00 AM PDT

FDA’s General Controls for Medical Device Manu...

Friday, 17th March, 2017
Time : 01:00 PM EST | 10:00 AM PST

FDA Guidelines for IoT (Internet of Things) Wire...

Friday, 18th August, 2017
Time : 01:00 PM EDT | 10:00 AM PDT

FDA Medical Device Regulation – Design Control...

Friday, 25th October, 2019
Time : 01:00 PM EST | 10:00 AM PST

Virtual Seminar on Supplier Management in FDA-Re...

Friday, 5th March, 2021
Time : 11:00 AM EDT | 08:00 AM PDT

FDA Medical Device Regulation - Unique Device Id...

Friday, 18th November, 2022
Time : 01:00 PM EST | 10:00 AM PST

What you need to know about the FDA 510(k) Proce...

Friday, 3rd February, 2023
Time : 01:00 PM EST | 10:30 AM PST

21 CFR Part 11 Conformance for Medical Devices

Friday, 14th April, 2023
Time : 01:00 PM EST | 10:00 AM PST

FDA Labeling Requirements for Medical Devices

Wednesday, 28th August, 2024
Time : 01:00 PM EST | 11:00 AM PST

Equipment Validation, Tracking, Calibration and ...

Friday, 30th August, 2024
Time : 01:00 PM EST | 10:00 AM PST

Recorded Webinar

Global Medical Device Risk Management - Demystifying European, FDA and ISO Requirements

timelapse 60 mins with 10-15 mins of Q and A

Note:

This webinar occured in the past
Along with recorded webinar, copy of presentation slides will be shared
Recorded Webinar can be played unlimited times

Speaker/Presenter

Short Abstract

The webinar will provide guidance for preparing medical device Risk Management Plans, Reports and Files in compliance with current international regulatory requirements.

The presentation will dissect the risk management requirements in ISO 14971:2007 (FDA Recognized) and contrast them with the requirements of the European Directives as pointed out in EN ISO 14971:2012.

After this session, the participants should be prepared to answer these questions for their organizations:

  • Does your RM system require revision to address forgotten aspects of ISO 14971:2007 or the “content deviations” described in EN ISO 14971:2012?
  • Do your existing RM files and subordinate documents require updates to conform with your (updated) procedures?
  • What impact will the ISO/TR 24971:2013 guidance have on your RM system?


Webinar topics will include:

  • Background
  • General Requirements
  • Risk Assessment
  • Risk Control
  • Risk/benefit Analysis
  • Overall Residual Risk Evaluation
  • Risk Management Report
  • Production and Post-Production Information


Apply for this webinar

Who should attend

Anyone who is interested in learning more on Medical Device Risk Management

Content Disclaimer

Contents in our website are from external websites. Links to and content from external website are provided for the convenience of users. Biopractice.com takes no responsibility for the content of such links and websites.

//