Senior Quality Assurance and Compliance expert with 15+ years of specialized experience in medical device software validation and regulatory compliance. Proven track record implementing FDA-compliant software development lifecycles and quality management systems for innovative diagnostic platforms, including NGS and IVD technologies. Extensive experience leading IEC 27001 certifications, clinical trial software validation, and cloud service compliance initiatives. Known for successfully bridging technical complexity with regulatory requirements while maintaining operational efficiency
Core Competencies:
- Regulatory & Quality Systems
- FDA Medical Device Software Compliance (21 CFR 820, 21 CFR Part 11)
- ISO Quality Management Implementation (ISO 13485)
- Information Security Management Systems (ISO/IEC 27001)
- Risk Management Framework Implementation (ISO 14971)
- Medical Device Software Lifecycle Management (IEC 62304)
- Software Validation & Verification
- Clinical Trial Software Validation
- Cloud Service Validation (SaaS, PaaS)
- Computer System Validation
- Electronic Data Collection (EDC) Systems Validation
- Program Management & Implementation
- Software Development Life Cycle (SDLC) Implementation
- Multi-vendor System Integration
- Compliance Remediation Programs
Recent engagements
- Assisted several NGS (Next Generation Sequencing) human IVD and LDT startup companies in developing sustainable, FDA-compliant, and agile software development processes, including IEC 27001:2022 certification with zero major nonconformities.
- Developed comprehensive software QMS framework aligned with IEC 62304, FDA, and ISO requirements
- Implemented risk-based computer system validation program for QMS and Production systems
- Established information security procedures meeting IEC 27001 requirementsÂ
- Managed multi-vendor integration of automated equipment and custom detection systems
Interested in chatting with me? I’d love to discuss my ideas, experience, and engagements!
Get in touch with me either via the contact page on this site, via LinkedIn, or by sending an email to leslie AT lesliedow.com.