11:14 a.m. – 11:14 a.m. Tuesday 22nd

Audience

Test Manager, QA Manager, Product Owner, Business Analyst, CTO

Required

Notebook, laptop.

Key-Learning

What are the rules and requirements when testing an FDA regulated product
How to use agile testing approaches and still maintain FDA compliance
Testing medical devices that are regulated
Testing medical information systems that manage patient data
Tips and tricks for generating the compliance paperwork from your project artifacts

There is a need for agile testing approaches in complicated domains such as medical device testing.

In this session I would like to discuss my experiences with testing software applications in industries such as healthcare that are heavily regulated by the Government, with strict requirements for validation, traceability and evidence.

The examples will be based on experiences and real-world case studies from our clients in the healthcare space (hospital systems, medical device companies, etc.) and include the role of manual testing, exploratory testing and test automation in such industries.

We shall also cover the rules, regulations, and reporting requirements, and present ways to harness agile approaches, and yet be able to provide the information needed by regulators and other audit agencies to ensure the products being tested are compliant.

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