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

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Last Recorded Date: Aug-2009

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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 ( 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.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

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