Revolutionary Change in FDA Software Regulation

MessageThis Webinar is over
Date Aug 28, 2018
Time 10:00 AM to 11:00 AM
Cost $ 150.00
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


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