FDA-Regulated Environment Development Team - 2017

Overview:  
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: [email protected]

Others Details

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