Webinar Duration: 60 minutes

RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)

SPEAKER: Casper (Cap) Uldriks

Device cybersecurity programs protect and the performance of device based software or standalone software to assure the safe use of the device. The development and implementation of cybersecurity programs in the device industry requires the use of the FDA’s premarket and postmarket information requirements to get to market and to stay on the market. The FDA relies on the use of voluntary standards developed by the National Institute of Standards and Technology (NIST) and voluntary information sharing organizations to meet cybersecurity challenges. Manufacturers have additional business issues to address, such as recovery and public disclosure of cyberattacks, especially when private medical records are extracted, which leads to fines in the millions of dollars per intrusion.

Why should you Attend: This webinar will identify the FDA’s fundamental premarket and postmarket requirements that involve software. Nothing is taken in blind faith when you ask the FDA to let you market your product. The burden of design factors requires well informed considerations about how you protect your product’s software and how you remain current as cyber exploits become increasingly sophisticated. Likewise, you have regulatory burdens and options if a cybersecurity problem is associated with or manifested in your device. Your cybersecurity efforts should include design planning, postmarket vigilance, training for employees and an action plan for managing an attack. These basic considerations will be identified and discussed in the webinar.

Areas Covered in the Session:
– FDA’s Cybersecurity Premarket Design Information
– FDA’s Postmarket Controls
– Voluntary Controls
– Cybersecurity Training
– Recovery Plans

Who Will Benefit:
– Regulatory Affairs
– Quality Assurance
– Software Design Engineers
– Manufacturing
– Complaint Dept
– Hospital Risk Dept
– Own Label Marketers

Casper (Cap) Uldriks, through his firm “Encore Insight LLC,” brings over 32 years of experience from the FDA. He specialized in the FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. His comments are candid, straightforward and of practical value. He understands how FDA thinks, how it operates and where it is headed. Based on his exceptionally broad experience and knowledge, he can synthesize FDA’s domestic and international operational programs, institutional policy and thicket of legal variables into a coherent picture. Professional credentials: JD – Suffolk University, licensed in Massachusetts and the District of Columbia; M.Div in psychology – Boston University with internship through Harvard University.