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Using an IQ / OQ / PQ Approach to Validating Medical Device Software
- Development of software test plans.
- How to apply IQ / OQ and PQ techniques to software?
- Risk based software testing.
- How does Software Validation relate to Design Validation?
- Typical software tests.
- What is the appropriate sample size for software testing?
- Software issue tracking.
- How to address open issues when releasing software.
Overview of the webinar
This medical device software validation training will show how you can validate software using IQ / OQ / PQ methodologies, typically employed for medical device process validation
Who should attend?
- Systems Engineers
- Software testers
- Test Engineers
- Quality System Auditors
- Engineering Managers and personnel
- Regulatory Affairs
- Software Vendors
Why should you attend?
Software Validation is a hot topic with the FDA because of the numerous medical device recalls related to faulty software.
This webinar provides a method for performing thorough software validation using well established methods of Installation Qualification, Operational Qualification and Performance Qualification. These terms are not commonly used with software, but these processes can be successfully applied to software validation in order to reduce the likelihood of enduring a software recall.
Faculty - Ms.Mercedes Massana
Is the founder and CEO of MDM Engineering Consultants, a consulting firm that provides engineering and quality consulting services in the medical device, biotechnology, and pharmaceutical industries. Mercedes has over twenty-five years of experience in the Medical Device industry. ? Extensive experience in developing processes within the constraints of FDA/lSO Quality Systems. She has been responsible for establishing processes and leading groups of engineering in the following disciplines: Risk Management, Requirements Management, Verification and Validation, Process Improvements, Project Management, Software Systems Validation, Process Validation. Mercedes is an ASQ certified Biomedical Auditor (CBA), Software Quality Engineer (CSQE), Quality Manager (CQMa) and Quality Auditor (CQA). Mercedes is well versed in FDA and ISO regulations.