Compliance Trainings, Canada
2014-09-11
The use of mobile apps as a medical device continues to mushroom. Approximately 85% of adults use cellphones. They offer a fertile field for mobile apps used for medical purposes, some good, some not. How do you decide which healthcare app is safe? Can someone hack an app you rely on for life supporting / life sustaining medical care? Yes. Patients and caregivers receive and install “app updates” with no idea what just happened and place themselves and even others in jeopardy. FDA has started to implement a regulatory approach and is overwhelmed now with that task. How much can FDA do? How will you know about the risks faced by the healthcare sector and you as an individual? FDA is not the only regulatory stakeholder. The FTC exercises overlapping regulation. Are the two agencies in-sync with each other? Each agency is concerned about false or misleading claims. Marketers of standalone medical app software may have no clue about the FTC’s and FDA’s regulatory purview and enforcement authority over how a mobile app is marketed. That knowledge gap can be brutal, expensive and bring your business to a standstill. Areas Covered in the Session : FDA Strategy and Policy Medical App Definition Institutional and Home Use Risks Cybersecurity Labeling Claims Enforcement Who Will Benefit: Regulatory Affairs Manager Quality Assurance Manager Software Design Engineers Manufacturing Manager Complaint Dept. Hospital Risk Department Software program marketers IT security managers Marketing managers Home Healthcare Services Healthcare Information Protection Capital Venture Firms Medical Device Consultants Price Tags: Live Single Live : For One Participant $ 249 Corporate Live : For Max. 10 Participants $ 899 Recording Single REC : For One Participant - Unlimited Access for 6 Months $ 299 For more information and enquiries contact us at Compliance Trainings 5939 Candlebrook Ct,
Mississauga, ON L5V 2V5,
Canada
Customer Support : #416-915-4458
Email : support@compliancetrainings.com
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