Webinar On The FDA Medical Device Approval Process: Preparation of 510(k)s, IDEs, PMAs
February 5, 2015 - Mississauga ON CACompliance Trainings
uttam@compliancetrainings.com
Phone:4169154458
This web presentation presents an overview of the requirement to obtain FDA permission to market a Medical Device products. 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