ComplianceOnline

The Future of the 510K: Can the past predict the future?

Instructor: Michael Drues
Product ID: 701385
Training Level: Intermediate to Advanced
  • Duration: 60 Min

recorded version

$299.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

$500.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This 510K webinar will review the proposed changes currently being discussed regarding the 510K program and how these changes will likely impact the medical device industry in the future.

Why should you Attend:
To be aware of and understand the proposed changes currently being discussed regarding the 510K program and how these changes will likely impact the medical device industry in the future.

The 510K, one of the two primary pathways available to medical device manufacturers to bring new products to the market in the United States, has been the workhorse of the medical device industry for the past three decades.

But some say there is a “perfect storm” brewing: more product recalls being reported by the media, a new administration in Washington, D.C., and a newly appointed FDA commissioner who has said “there obviously have been some problems” at the Center for Devices and Radiological Health and has designated device reform as “a high priority” for the immediate future.In fact, this storm may have been developing for some time as former FDA Commissioner David Kessler described the device center as “dysfunctional” and “in meltdown.”

Will the 510K as it currently exists today remain the dominant pathway to get medical devices on to the market in the future? Only time will tell but attendees of this webinar will come away with a better understanding of the important issues being debated today and a greater insight on how to plan for the future.

Areas Covered in the seminar:

  • With this “perfect storm” rapidly approaching, what do device manufactures need to know now to weather this storm without becoming lost at sea or worse? During this interactive webinar, participants will:
    • Understand the challenges and limitations of the 510K program as it currently exists.
    • Identify several case studies with lessons to be learned including what to do and what not to do Appreciate the implications of “The Medical Device Safety Act of 2009” (HR 1346) and anticipate likely changes to the regulatory process should the bill become law.
    • Discuss some of the proposed solutions currently under debate and consider what the future will hold for the 510K program.

Course material:

Attendees will get handout including recommended readings and references prior to the webinar.

Who will benefit:

This webinar is designed for medical device professionals involved in the design, development, and manufacture of medical devices.
  • Scientists
  • Engineers and technicians working on device design and development
  • Product and product development managers
  • Business development managers
  • Marketing managers
  • Quality personnel
  • Regulatory affairs professionals
  • Investment and acquisition specialists and field service engineers will all benefit from this webinar

Instructor Profile:
Michael Drues, Ph.D., is President of Vascular Sciences (www.vascularsci.com) in Grafton, Massachusetts. Vascular Sciences offers a full range of consulting services to medical device, pharmaceutical and biotechnology companies including: prototype design, product development, testing and evaluation, animal and clinical trials, business development, strategic planning, technology assessment and regulatory affairs. Dr.Drues received his B.S., M.S., and Ph.D. degrees in Biomedical Engineering from Iowa State University in Ames, Iowa. He has worked for and consulted with leading medical device, pharmaceutical and biotechnology companies ranging in size from start-ups to Fortune 100 companies. He also works on a regular basis for the U.S. Food and Drug Administration (FDA).

Dr. Drues is an Adjunct Professor of Medicine & Biotechnology at Northeastern University (Boston), Steven’s Institute of Technology (Hoboken), Boston College (Boston), University of Wisconsin (Madison), Drexel Medical School (Philadelphia) and University of California (Irvine). He regularly teaches both undergraduate and graduate courses in pathophysiology, biotechnology, regulatory affairs and clinical trials. Dr. Drues conducts seminars and short courses for medical device, pharmaceutical and biotechnology companies, the European Patent Office and the FDA. Current offerings include: Designing Cardiovascular, Peripheral and Neurovascular Devices Designing Gastrointestinal and Urinary Devices Minimally Invasive Technologies Combination Products: Medical Devices Meet Drugs, Biologics & Beyond™ Overview of Biotechnology Emerging Trends in the Medical Device Industry™ Big Picture Issues in Clinical Trials™ Regulatory Affairs for Non-Regulatory Professionals.

Follow us :
ComplianceOnline Banking Summit 2016 | Risk Management and Data Security - 80390SEM
ComplianceOnline Medical Device Summit 2017

Product Reviews

This product hasn't received any reviews yet. Be the first to review this product! Write review

Best Sellers
You Recently Viewed
    Loading