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
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
