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

MessageThis Webinar is over
Date Apr 16, 2014
Time 13:00
Cost $899.00

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

Price Tags:
Single Live : For One Participant
$ 249
Corporate Live : For Max. 10 Participants
$ 899
Single REC : For One Participant - Unlimited Access for 6 Months
$ 299

Speaker Profile:
Albert A. Ghignone, MS, RAC is the CEO of AAG Incorporated. For more than 30 years his focus has been on FDA related matters in regulatory affairs, quality assurance and clinical affairs. He has expertise in dealing with all aspects of the FDA approval process for drugs, biologics, medical devices and generic drugs. He has worked in every major segment of the industry-research, quality assurance, regulatory affairs, manufacturing and clinical.

Contact us:
5939 Candlebrook Ct,
Mississauga, ON L5V 2V6,
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