Compliance Trainings, Canada
2015-02-05
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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