Medical Device IVD Regulations Training - Live Webinars, Recordings & CDs

How to Prepare for the New EU Medical Device Regulations

webinar-speaker   Richard Young

webinar-time   90 Min

Product Id: 705513

The course is designed to review critical elements of the new regulations and will be run as an interactive 2 hour course designed for business leaders with a good working knowledge of current requirements.

Recording Available

* Per Attendee $279


FDA Inspections: What Regulations Expect

webinar-speaker   Joy McElroy

webinar-time   90 Min

Product Id: 705346

Attend this webinar to increase one’s knowledge of FDA inspections, what inspectors are looking for and expect to see and not to see in manufacturing facilities. It will provide an in-depth understanding of how to prepare for unannounced FDA audits and inspections.

Recording Available

* Per Attendee $249


FDA Guidance on RUO (Research Use Only)/IUO (Investigational Use Only) Products

webinar-speaker   Dev Raheja

webinar-time   60 Min

Product Id: 703898

This FDA guidance training on RUO (Research Use Only) and IUO (Investigational Use Only) products will enumerate FDA requirements for research use only and investigational use only IVD products. The webinar instructor, an industry expert, will highlight appropriate labeling and distribution practices for RUO and IUO products and detail instructions for use of an IVD product labeled RUO or IUO.

Recording Available

* Per Attendee $25


LDT including CDx; CLIA versus FDA's Authority

webinar-speaker   Abdel Halim

webinar-time   60 Min

Product Id: 703399

This webinar will explain the regulatory path of an in vitro diagnostic (IVD) and Laboratory Developed Test (LDT). It will discuss the CLIA regulations for Laboratory Developed Tests (LDTs), including companion diagnostics (CDx) and how these differ from the FDA’s authority.

Recording Available

* Per Attendee $229


cGMPs for Medical Devices, Including In Vitro Diagnostic Devices

webinar-speaker   David Lim

webinar-time   90 Min

Product Id: 702349

This 90-minute webinar will discuss the current good manufacturing practices (cGMPs) for medical devices and in vitro diagnostic devices.

Recording Available

* Per Attendee $229


Processes for 510(k) Clearances for In Vitro Diagnostic/IVD Device Products via FDA-CDRH

webinar-speaker   Alfredo J Quattrone

webinar-time   60 Min

Product Id: 700442

This 510(k) Clearances training/webinar will provide valuable assistance to all regulated companies that need to validate their systems.

Recording Available

* Per Attendee $149













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