Revolutionary Change in FDA Software Regulation

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Category Software Regulation, Cybersecurity, compliance software, compliance management software, regulatory compliance software, compliance software solutions, software developer

Deadline: August 26, 2018 | Date: August 28, 2018

Venue/Country: Online, U.S.A

Updated: 2018-06-07 14:34:36 (GMT+9)

Call For Papers - CFP

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: supportcompliance4All.com