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
Quality Assurance Directors
In-House Legal Counsel
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
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