America's Top Tradeshow Directory | Events In America
Facebook Linked In Twitter Videos
A Comprehensive View of FDA Regulations for Medical Devices

A Comprehensive View of FDA Regulations for Medical Devices

Views: 546

06/14/2016 - 06/15/2016

Venue TBD

Boston, MA 02139

New Search Contact This Event

Share This Event


Add to Your Calendar 06-14-2016 00:00:00 06-15-2016 00:00:00 11 A Comprehensive View of FDA Regulations for Medical Devices Don’t let a common misunderstanding get you into trouble! There is more to the US Medical Device Regulations than Part 820. Companies that don’t understand will face regulatory scrutiny and receive FDA Form 483s and Warning Letters. Recently a device manufacturer got a Warning Letter relating to updates to shipped devices, which said, “The Quality Manager stated he was unaware of the corrections and removal reporting and recordkeeping requirements.” This two day interactive course on FDA regulations for medical devices will: Cover more than just the Quality Management SystemProvide an overview of regulations and how they fit togetherExplain Unique Device Identification (UDI) in detail, covering the issues device manufacturers will face as well as timeline for implementationHelp attendees understand the four major elements of the US regulatory structure: laws, regulations, guidance, and consensus standards Learning Objectives:Learn the law, regulations, and policies that FDA applies for medical deviceUnderstand the requirements to market a medical device in the US including device classification and conformity assessment pathsUnderstand the quality management systems that govern the design, manufacture, installation, and servicing of medical devices for the US marketLearn how UDI will affect medical devices and how to prepare for implementationUnderstand the rules for Medical Device Reports (MDRs) and their relationship to complaints Who will Benefit:This seminar course will be beneficial for the following personnel in medical device manufacturing companies and in medical device supply chain: Quality managersQuality engineersQuality assurance and quality controlRegulatory affairs managersRegulatory affairs professionalsR&D managers Topic Background:In the US, medical devices organization uses risk classes and panels... Venue TBD ComplianceOnline true MM/DD/YYYY

Event Location Map

Paid membership required to see this information

Don’t let a common misunderstanding get you into trouble! There is more to the US Medical Device Regulations than Part 820.

Companies that don’t understand will face regulatory scrutiny and receive FDA Form 483s and Warning Letters. Recently a device manufacturer got a Warning Letter relating to updates to shipped devices, which said, “The Quality Manager stated he was unaware of the corrections and removal reporting and recordkeeping requirements.”

This two day interactive course on FDA regulations for medical devices will:

Cover more than just the Quality Management System
Provide an overview of regulations and how they fit together
Explain Unique Device Identification (UDI) in detail, covering the issues device manufacturers will face as well as timeline for implementation
Help attendees understand the four major elements of the US regulatory structure: laws, regulations, guidance, and consensus standards

Learning Objectives:
Learn the law, regulations, and policies that FDA applies for medical device
Understand the requirements to market a medical device in the US including device classification and conformity assessment paths
Understand the quality management systems that govern the design, manufacture, installation, and servicing of medical devices for the US market
Learn how UDI will affect medical devices and how to prepare for implementation
Understand the rules for Medical Device Reports (MDRs) and their relationship to complaints

Who will Benefit:
This seminar course will be beneficial for the following personnel in medical device manufacturing companies and in medical device supply chain:

Quality managers
Quality engineers
Quality assurance and quality control
Regulatory affairs managers
Regulatory affairs professionals
R&D managers

Topic Background:
In the US, medical devices organization uses risk classes and panels. Devices fall under regulations and product codes that determine the available conformity assessment paths and provide requirements for specific cases.

The Quality System Regulation, in Part 820, provides the quality management system required for medical devices in the US. Device design, production, installation, and servicing fall under Part 820. This part of the regulations include management responsibility for the system, design requirements, purchasing, manufacturing processes and controls, release for distribution, record keeping, etc. After release, a device is subject to a variety of other requirements ranging for complaint management to medical device reports to recalls. Each of these requirements is in a separate part of the regulations.

Note:
Use coupon code NB5SQH8N and get 10% off on registration.

For Registration:
http://www.complianceonline.com/fda-regulations-for-medical-devices-seminar-training-80118SEM-prdsm?channel=eventsinamerica

Not sure if you want to exhibit at or attend the A Comprehensive View of FDA Regulations for Medical Devices? See the panels below to get the information you need to make an informed decision.

All information in Events In America is deemed to be accurate at the time we add it, and we take steps to verify all details and update our records when new information is provided, but as people, events and circumstances change, we caution users to independently confirm all information. EventsInAmerica.com and Events In America LLC make no guarantee of accuracy and assume no liability for inaccurate information.

Website: http://www.complianceonline.com/fda-regulations-for-medical-devices-se...
Conference/Event Dates: 06/14/2016 - 06/15/2016
Conference/Event Hours: 8:30 AM - 4:00 PM
Classification: B2B
Primary Industry: Sciences
Other Industries: Business, Manufacturing, Medical, Sciences
Estimated Attendance: 30
Cost to Attend: One Registration - $1499
Audience: Quality managers
Quality engineers
Quality assurance and quality control
Regulatory affairs managers
Regulatory affairs professionals
R&D managers
R&D engineers
Venue: Venue TBD
Show Owner:ComplianceOnline

Booth Size Booth Cost   Available Amenities
Call for information.   Electricity: n/a
  Water: n/a
  Generator: n/a
  Marketing Vehicles Allowed: Call
Other Booth Sizes Available: n/a

Advance Networking

How do I show up here?
 

Personal Notes

Add a note here, it is only visible by you.

New Search Contact This Event