Online Seminars (Recorded)

Medical Devices and IVDs

FDA 510(k)

Recorded | FDA 510(k): Preparation, Submission, and Clearance | 60 Minutes | Read More Here

Recorded | 510(k) Drafting Seminar Series | 5 Sessions – 60 Min Per Session | Read More Here.

Recorded | How to Format Succinct and Comprehensive 510ks and PMAs | Two Days of Seminars | Read More Here.

Design Control

RecordedDemystifying Design Control: Design History File (DHF), Device History Record (DHR), and Device Master Record (DMR) | 60 Minutes | Read More Here

UDI

RecordedImplementing UDI systems | 60 Minutes | Read More Here

US Laws and Regulations

Recorded | US Laws and Regulations for Medical Devices including In Vitro Diagnostic Devices (IVDs) |78 Minutes | Read More Here

Complaint Handling and MDR

Recorded | Complaint Handling and Medical Device Reporting (MDR) | 62 Minutes | Read More Here.  

Risk Management

Recorded Risk Management for Medical Devices and IVDs: Systematic and Holistic Approaches | 74 Minutes | Read More Here.

Premarket Approval (PMA)

Recorded | PMA Drafting Seminar Series | 8 Sessions – 90 Min Per Session | Read More Here.

Recorded | How to Format Succinct and Comprehensive 510ks and PMAs | Two Days of Seminars | Read More Here.

Learn about PMA Drafting Seminars (Recorded) Available

Last Updated: 2015-12-23

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