Download the Course Brochure

Availability: Right Now (Interactive Presentation)

Duration: 50 min. (the average time to complete the training program).
Description: This Webinar course will introduce you to the FDA Regulation for Medical Device, IVD and Combinations products:

  • 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

Links and reference to FDA support material and guidelines are also provided during the presentation.

Why Should You Attend:
The Food and Drug Administration (FDA) was founded in 1906 to better manage the public health of the United States with respect to goods and services. The manufacturer’s FDA registration number is required for all companies producing, distributing or selling goods in the nation. Owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States (U.S.) are required to register annually with the FDA. Most establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those devices. If a device requires premarket approval or notification before being marketed in the U.S., then the owner/operator should also provide the FDA premarket submission number (510(k), PMA, PDP, HDE). This Webinar will provide necessary tools to orient in this critical process.

Who Will Benefit:

  • Regulatory Affairs specialist
  • R&D Engineers
  • Medical Affairs specialist
  • Clinical Affair specialist
  • Quality Engineers
  • Marketing

Certification Requirements: Students must view the entire program and successfully pass an online, multiple choice final assessment with >80% passing grade.Certificate will be printable in PDF format immediately after satisfying requirements.

Online Training Programs Includes:

90 days of 24/7 access to individual eLearning courses.
Answer to questions submitted during the webinar.
An online final assessment with multiple choice questions.
A Certificate of Completion.

Training Course held by Dr. Candida Fratazzi:

Candida Fratazzi

With over 25 years’ experience in biomedical research, Dr. Fratazzi devised the SCIO concept. She founded BBCR Consulting in 2009, with the objective of actively contributing to the ongoing innovation in clinical development. Dr. Candida Fratazzi holds an higher degree in Immunology and is an Orphan disease expert. She worked in Cystic Fibrosis, Fabry disease, Gaucher’s disease, Multiple Sclerosis and more. Dr. Fratazzi consults to biotech, pharmaceutical, and medical device companies advising her clients on clinical/regulatory development road-maps and cost-efficient trial designs. Read the full Bio

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