Former Senior FDA Official to Conduct ComplianceOnline Seminar on Medical Device Risk Management

Former Senior FDA Official to Conduct ComplianceOnline Seminar on Medical Device Risk Management

Online PR News – 12-August-2014 – Chicago, IL – ComplianceOnline,the leading GRC advisory network and an ex-FDA official Dr. Harvey Rudolph will conduct a two day seminar on medical device risk management requirements in the US, EU, and other parts of the world.

September 11 and 12, 2014– Chicago, IL

ComplianceOnline, the leading governance, risk and compliance advisory network with over 500 experts in various regulatory subjects, today announced a seminar on Medical Device Risk Management A to Z - Best Practices for Effectiveness and Efficiency. The two day seminar led by former senior FDA official Harvey Rudolph will be held on September 11 and 12 in Chicago, IL.

During the course, Dr. Rudolph will provide insights on the guidance contained in the new ISO TR 24971 and how to integrate risk management into your quality management system.

Seminar instructor Dr. Harvey Rudolph is an independent risk management consultant specializing in process development and training in risk management. His 37 years’ experience with medical devices include 25 years at FDA, where he held a variety of positions and retired as deputy director of the medical device laboratory. Dr. Rudolph is one of the authors of ISO 14971. Having trained and consulted for numerous large and small companies throughout the world, he brings a wealth of knowledge and practical experience to this risk management workshop.

During the two day seminar Dr. Rudolph will address the fundamentals of risk management and current best practices for ISO 14971 compliance. He will discuss risk management requirements in the US, the EU, and other parts of the world. Attendees will learn how to establish a quantitative risk management system that complies with EN/ISO 14971:2012. He will provide attendees tools necessary for effective risk management implementation in device manufacturing and marketing.

This seminar will be beneficial for individuals accountable for medical device risk management. Project managers, quality managers, R & D managers, regulatory and compliance mangers will benefit from attending this seminar.

Date: Thursday, September 11, 2014 (8.30 AM- 4.30 PM) and Friday, September 12, 2014, (8.30AM- 4.30 PM)

Location: Chicago, IL

Registration Cost: $1,699.00 per registration

Early bird discounts: For discounts on early registrations, please click here.

Register by phone: Please call our customer service specialists at +1-650-620-3937 or send an email to

For more information on ComplianceOnline or to browse through our trainings, please visit our website.

About ComplianceOnline

ComplianceOnline is a leading provider of regulatory compliance trainings for companies and professionals in regulated industries. ComplianceOnline has successfully trained over 35,000 professionals from 9,000 companies to comply with the requirements of regulatory agencies. ComplianceOnline is headquartered in Palo Alto, California and can be reached at ComplianceOnline is a MetricStream portal. MetricStream ( is a market leader in Enterprise-wide Governance, Risk, Compliance (GRC) and Quality Management Solutions for global corporations.

For more information please contact:

A Reuben Bernard
Manager of Program Marketing
2600 E Bayshore Rd
Palo Alto CA USA 94303
650-620-3937 phone
650-963-2530 fax