FDA-Regulated Environment Development Team - 2017

  • Check with publisher
  • Published date: May 15, 2017
    • Fremont, California, United States

The Agile approach is well established in other industries adoption of Agile

in medical device development has been increasing in the past five years.

Why Should you attend:
Medical device development struggles with huge pressures: the need for

innovation, keeping cost down, and minimizing time to market. With all its

success in other industries, it appears that the Agile approach be a huge

should help - but even after years of use and multiple reports, criticism of,

and doubts about, Agile methods exist in the medical device field.

Areas Covered in the Session:
Laying the Groundwork
Recognize your context
What Agile solves - and requires
Selecting a project to pilot
Change needs to be shepherded

Who Will Benefit:
Software Developers
Business Analysts
Requirements Analysts
Product Managers
Portfolio Managers

Speaker Profile:
Brian Shoemaker consults for healthcare products companies on computer

system validation, software quality assurance, and electronic records and

signatures. He has conducted validation both on product software and on

internal software, developed software quality systems, audited software

quality processes (including agile methodology), and evaluated 21 CFR Part

11 compliance.

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com

Full Details & Registration Link:

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