Healthcare Training by Compliance4all on Investigational Device Exemption

Overview:  

An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to FDA.

Areas covered in the session:

Learn the appropriate and expected regulatory strategies and guidelines for your IDE

Understand the application process and administrative action with your IDE

Know the responsibilities of the sponsor

IRB review and approval and expectations

What records and reports are expected and required

IDE refers to the regulations under 21 CFR 812

Know the procedures involved with the clinical studies and expectations

Understand that if the study involves a significant risk device, the IDE must also be approved by FDA

Who will benefit: 

This webinar will provide valuable assistance and guidance to medical device firms that are currently preparing or will prepare for IDE submissions. The employees who will benefit include: All levels of management and departmental representatives and those who desire a better understanding or a "refresh" overview of the IDE preparation and submission process, including:

Regulatory Affairs

Clinical Affairs

Quality and Compliance

Marketing & Sales 

Distributors/Authorized Representatives

Engineering/Technical Services/Operations

Consultants

Speaker Profile:

David Dills , Global Regulatory Affairs & Compliance Consultant, has an accomplished record with more than 26 years of experience within regulatory affairs, compliance and quality consultative services for early-stage/established Class I/II/III medical devices, IVDs, and bio/pharmaceutical manufacturers on the global landscape. 

Contact Detail:

Compliance4All DBA NetZealous,

Phone: +1-800-447-9407

Email: support@compliance4All.com

http://www.compliance4all.com/

Event Link : http://www.compliance4all.com/control/w_product/~product_id=500839LIVE?channel=mailer&camp=webinar&AdGroup=sciencedz_Dec_2016_SEO

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