FDA's Medical Device Software Regulation Strategy

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?

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

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, Valid till Dec 31st 2015.

For Registration:

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