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:
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.
Compliance4All DBA NetZealous,
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