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TODAY :
EVENT DATE
Jun 2016
MoTuWeThFrSaSu
  12345
6789101112
13141516171819
20212223242526
27282930   
EXPO DATE
Jun 2016
MoTuWeThFrSaSu
  12345
6789101112
13141516171819
20212223242526
27282930   

Venue

Venue TBD Washington , District of Columbia
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FDA's Medical Device Software Regulation Strategy

30 0

Overview

The growth of the medical software industry outpaces the design of FDA's regulatory process. In some instances clinicians have weighed the risk of software failure against the benefits of using a device at all. Device software is often used in conjunction with other software-based devices, but their interoperability was never anticipated.

  • How can you anticipate and defend against the malicious remote hacking and shut down of an insulin infusion pump?
  • Can one software program defeat the performance capability or back up safety features of another software program?
  • When interoperability surface, which software manufacturer takes the lead to solve the problem and deal with proprietary software issues?

This seminar will focus on addressing these concerns and educating participants on FDA’s recent medical device software regulation strategies.

Learning Objectives:

  • Understanding FDA legal authority
  • Applying FDA classifications / risk controls
  • Understanding FDA and NIST software guidance
  • Identifying the quality system regulation for risk management, software verification and validation
  • Identifying cybersecurity issues and developing a planned response
  • Identifying and resolving interoperability issues

Who Will Benefit:

  • Regulatory Affairs Managers
  • Quality Assurance Managers
  • Software Design Engineers
  • Manufacturing Managers
  • Compliance Department Personnel
  • Hospital Risk Department Personnel

Note:
Use coupon code NB5SQH8N and get 10% off on registration.

For Registration:

http://www.complianceonline.com/fda-medical-device-software-regulation-strategy-seminar-training-by-ex-fda-official-seminar-training-80242SEM-prdsm?channel=eventsinamerica

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