Revolutionary Change in FDA Software Regulation

Overview:
It is not about giving an OK to products, it is about trusting the
manufacturer to do the right thing. Overall, your regulatory
approach to software regulation needs to ease up and reap the
benefits where they apply. Your company may even save money, a
nice benefit.

Why should you Attend:
The scope of your program should be re-evaluated to identify your
least burdensome approach. You can learn what matters and what
does not. You can implement faster ways to move products into
the marketplace and decide whether or not you want to involve
FDA in your cybersecurity problems. You can prepare now to
qualify for the new Digital Health initiative, but you have
homework to do first.

Areas Covered in the Session:
21st Century Cure Act Impact
Software no longer under FDA jurisdiction
Changes in premarket requirements
Voluntary controls short cuts
Postmarket reporting options
Digital Health Initiative - FDA clearance not required

Who Will Benefit:
Regulatory Affairs Directors
Software Designers / Specification Developers
Production Managers
Quality Assurance Directors
In-House Legal Counsel

Speaker Profile:
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.

Event Fee: One Dial-in One Attendee Price: US $150.00

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]