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
Recorded Webinar
FDA’s General Controls for Medical Device Manufacturers
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
“General controls” are the basic requirements that every medical device manufacturer must meet to legally sell their device in the US. And for most Class I devices, these are the ONLY FDA requirements that must be met. Recent legislation has changed some of the requirements, too – the Device Listing and Establishment Registration process, for example. This webcast outlines FDA’s general controls, including Medical Device Reporting (MDR) and recall requirements for medical device manufacturers, and brings you up to date on recent changes, and provides sources for more information.
This presentation will cover the following areas :
- Establishment Registration & Device Listing.
- Adulteration
- Misbranding
- 510(k)
- Records & Reports
- Banned Devices
- Notification & Repair, Replacement or Refund
- Quality System Regulations (QSR)
- Medical Device Reporting (MDR)
- Recalls
Who should attend
Medical Device companies/professionals including
- Manufacturing
- Regulatory Affairs
- Clinical Affairs
- Quality Professionals
- CROs
- Consultants, Contractors/Subcontractors
- Sales and Marketing
- Senior and Executive Management
- Anyone Interested in Learning More About US FDA Regulations
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.