FDA Regulation, 3D Printing and Medical Devices

Speaker

Instructor: Rachelle D Souza
Product ID: 704846

Location
  • Duration: 75 Min
This webinar on 3D printing will cover FDA's expectations regarding the design, manufacture, testing and approval of 3D printed medical devices.
RECORDED TRAINING
Last Recorded Date: Jul-2020

 

$229.00
1 Person Unlimited viewing for 6 month info Recorded Link and Ref. material will be available in My CO Section
(For multiple locations contact Customer Care)

$299.00
Downloadable file is for usage in one location only. info Downloadable link along with the materials will be emailed within 2 business days
(For multiple locations contact Customer Care)

 

 

Customer Care

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Why Should You Attend:

The Food and Drug Administration (FDA) is responsible for the approval of medical devices in the United States of America. Today 3D printing is used in a wide variety of applications, even for the manufacture of medical devices. So what are FDA’s current thoughts regarding the approval of 3D printed medical devices?

In this session, medical device manufacturers, software developers, engineers, validation experts, 3D printing raw material manufacturers and suppliers, regulatory and quality professionals, will be informed of FDA’s expectations regarding the design, manufacture and testing of 3D printed medical devices. Those interested in 3D printing technology will be well briefed too.

Areas Covered in the Webinar:

  • An Introduction to 3D Printing (includes brief history, applications, types of 3D printers, 3D printing process, terminology, advantages and challenges)
  • An Introduction to Medical Devices & Overview of Medical Device Regulation in USA (what are medical devices, medical device classes and types of medical device submissions to US FDA)
  • 3D Printing of Medical Devices & FDA’s current thoughts (including technical design, manufacture and testing considerations for approval)

Who Will Benefit:

The following professionals from the Medical Device industry will benefit from this training:

  • Manufacturing
  • Production
  • Product management
  • R&D
  • Software developers and vendors
  • Engineers
  • Validation experts
  • 3D printing raw material manufacturers and suppliers
  • Regulatory and quality professionals
  • Anyone interested in 3D printing technology and / or medical devices

Instructor Profile:

Rachelle D’Souza, CEO of Regulatory Heights Inc., has successfully licensed various medical and consumer products and facilities with international regulatory authorities / agencies for multinational and start-up companies.

Her expertise also includes clinical trial master file documentation, and the design and maintenance of globally compliant quality, safety / pharmacovigilance and medical information systems.

At Regulatory Heights Inc., Rachelle continuously monitors the current regulatory environment and utilizes regulatory intelligence as a strategic business driver for her clientele. Her numerous articles on the latest international regulatory developments have been published in print and on-line by regulatory professional associations and industry magazines around the world.

Her versatility has enabled Regulatory Heights Inc. to support companies, in particular, start-ups with the licensing of their drugs and medical devices in international markets.

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Refund Policy

Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).

 

 

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