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

Event Details

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

Time: February 5, 2015 from 1pm to 2pm
Location: Online
Street: 5939 Candlebrook Court
City/Town: Mississauga
Website or Map: https://compliancetrainings.c…
Phone: 4169154458
Event Type: webinar
Organized By: Compliance Trainings
Latest Activity: Dec 12, 2014

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Event Description

On Going Christmas Offers: Offer valid till 1 st January 2015

1. Register an attendee for Single Live:

Get 10% of on every Registration

First 10 attendees will receive recording Access to the webinar for No Additional Cost

For Coupon Code call customer support:  416-915-4458

2. Register your Group for Corporate Live:

Get 15% of on every Registration

Every group registrant will receive Recording Access to the webinar for No Additional Cost

For Coupon Code call customer support: 416-915-4458

3. Unlimited viewing for 4 days

4. The discounted amount will appear after entering the Coupon Code in the Secure Check Out Page

Description :

This 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 system

Preparing contents of the 4 types of 510(k)s

Preparing contents of an IDE

Preparing contents of a PMA

Non-significant risk devices

Significant risk devices

Who Will Benefit:

Regulatory Affairs Personnel

Quality Personnel

Clinical Personnel

Research Personnel

Manufacturing Personnel

Auditors

Legal Personnel

Personnel who require an understanding of the FDA Medical Device Approval Process

Price tags:

Live

Single Live : For One Participant

$ 249

Corporate Live : For Max. 10 Participants

$ 899

Recording

Single REC : For One Participant - Unlimited Access for 6 Months

$ 299

For more information and enquiries contact us at

Compliance Trainings

5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada 
Customer Support : #416-915-4458 
Email : support@compliancetrainings.com

For more information about this event please visit

https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1405

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