FDA Registration: Medical Devices, In Vitro Diagnostic (IVD) and Combination Products

FDA Registration: Medical Devices, In Vitro Diagnostic (IVD) and Combination Products is organized by OnlineCompliancePanel and would be held on Jun 1, 2017.

The target audience for this medical event for Regulatory Affairs specialist, R&D Engineers, Medical Affairs specialist, Clinical Affair specialist, Quality Engineers, Marketing, Quality Professionals, Product Development Professionals, CROs, Consultants, Senior Management, Contractors and Subcontractors.

Conference Objectives are :
• List and describe the regulations that govern both medical device classification and medical device submissions.
• Explain the medical device classification process.
• Discuss the importance of making proper medical device classification decisions.
• Explain the 510(k) submissions process.
• List and describe the 510(k) submissions pathways.
• List and describe the PMA submissions process.
• Explain the De Novo medical device submissions process.
• Explain the Human Device Exemption process.

Areas Covered in this Webinar :
• Device Classification
• Class I Medical Device
• Class I device exemptions
• Class II Medical Device
• Investigational Device Exemption (IDE)
• Class III Medical Device
• PMA Application Contents
• PMA filing
• Reclassification
• In vitro Diagnostics (IVD) - Basics
• Combination Product.

The medical device market is the largest market of all of the life sciences and it is generally valued at upwards of $90 billion with the expectation of continuous growth. This growth demands that the market be continually fed with new and innovative products. Regulation, here in the US as well as in the EU have made the approval of products for market a complex process requiring manufacturers, to ensure their own survival, to be fully knowledgeable of the regulatory submissions process.

Additional details will be posted as soon as they are available.