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Webinar On The FDA Medical Device Approval Process: Preparation of 510(k)s, IDEs

This web presentation presents an overview of the requirement to obtain FDA permission to market a Medical Device products.

On Going Christmas Offers: Offer valid till 1 st January 20151. Register an attendee for Single Live:Get 10% of on every RegistrationFirst 10 attendees will receive recording Access to the webinar for No Additional CostFor Coupon Code call customer support:  416-915-44582. Register your Group for Corporate Live:Get 15% of on every RegistrationEvery group registrant will receive Recording Access to the webinar for No Additional CostFor Coupon Code call customer support: 416-915-44583. Unlimited viewing for 4 days4. The discounted amount will appear after entering the Coupon Code in the Secure Check out PageThis web presentation presents an overview of the requirement to obtain FDA permission to market a Medical Device products.We will discuss the regulatory requirements and the various FDA submissions, the 4 types of 510(k)s and the contents of each. We will also discuss the contents and requirements for IDEs and PMAs, guidelines for each aspect of research are provided, as well as information on the structuring of submissions and post-approval documents. Attendees will get a better understanding of the FDA Medical Device Approval Process and the underlying scientific and regulatory principles involved. The course enables regulatory affairs professionals to provide the FDA with necessary information and obtain product approval.Areas Covered in the Session :Navigate the FDA medical device approval systemPreparing contents of the 4 types of 510(k)sPreparing contents of an IDEPreparing contents of a PMANon-significant risk devicesSignificant risk devicesWho Will Benefit:Regulatory Affairs PersonnelQuality PersonnelClinical PersonnelResearch PersonnelManufacturing PersonnelAuditorsLegal PersonnelPersonnel who require an understanding of the FDA Medical Device Approval ProcessPrice tags:LiveSingle Live : For One Participant$ 249Corporate Live : For Max. 10 Participants$ 899RecordingSingle REC : For One Participant - Unlimited Access for 6 Months$ 299For more information and enquiries contact us atCompliance Trainings5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada  Customer Support : #416-915-4458 

When

5 Feb 2015 @ 01:00 pm

5 Feb 2015 @ 03:00 pm

Duration: 2 hours

Timezone: GMT -5:00


Where

Online Webinar


Language

Englishen


Organised by

Compliance Trainings (deactivated)

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