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
FDA Medical Device Regulation : Overview of Complaint Handling and Medical Device Reports (MDR)
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
Complaint handling and reporting of adverse events related to the use of medical devices is a regulatory requirement in most regulated medical device markets. This course is an overview of FDA’s requirements for complaint handling and Medical Device Reporting (MDR). It includes definitions, regulatory requirements, how to respond to a complaint that reports a possible MDR, and how to file an MDR with the FDA.
The presentation will cover the following areas:
- What is a complaint?
- What are FDA’S requirements for complaints?
- What is an MDR?
- What are the FDA’s requirements for Medical Device Reports?
- How to file an MDR
Who should attend
Anyone involved in complaints and complaint handling, especially: Customer service, technical service, sales & marketing, RA/QA, and anyone seeking an overview of FDA’s complaint and MDR requirements.
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.