Bernard ("Bernie") O'Connor specializes in control and documentation of product development and the verification and validation (V&V) of design output of an R&D process. Bernard O'Connor is considered an expert in defining and planning the software life cycle. His consulting practice emphasizes the following:
- Hazard analysis
- Project planning and management
- Documentation of product development cycle
- Risk assessment
- Software development procedures
- Software Quality Assurance (SQA)
- Software requirements management
- Software verification and validation (V&V)
- 21 CFR
- FDA Design Control
- Training
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