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Regulatory and Quality Experience
My experience covers a wide variety of device types, clinical areas and markets on behalf of start-ups, small and medium SMEs, large multinational device and pharmaceutical manufacturers
Multiple Clinical Areas including...
General Oncology
Liver cancer
Lung cancer
Breast cancer
Pathology and Immunohistochemistry
Acute stroke
Heart failure
Liver fibrosis
Pre-term labor
Post-partum hemorrhage
Menstrual migraine
Sexual health
Dementia and Alzheimer's Disease
Parkinson's Disease
Muscular Dystrophy
Suicide prevention
Stimulant use disorder
Social anxiety
General surgery
Sleep apnea
Allergies
Acne
and many more...
Global Regulatory Analysis, Strategy and Submission Projects including...
USA
EU
UK
Japan
China
Brazil
Canada
Australia
South Korea
Saudi Arabia
and many more....
Multiple Device Types including...
Software Devices (SaMD)
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AI SaMD: software for acute stroke diagnosis from CT imaging (CADe)
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AI SaMD: software for real-time diagnostic analysis of endoscopy gastrointestinal imaging
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SaMD: PET imaging software for analysis and dosimetry for y90 SIRT for liver cancer
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AI SaMD: stroke - large vessel occlusion detection and notification software (CADt)
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SaMD: Image registration, display and multi-timepoint analysis software for CT, MR, PET SPECT and planar NM, for cancer diagnostics & treatment monitoring
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AI SaMD: lung nodule detection and diagnostic software (CADe & CADx)
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SaMD: Software devices for for image analysis and diagnostics from MRI scans for liver fibrosis and dementia
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Therapy delivery mobile apps, including CBT
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AI SaMD: Algorithms for detection and recording of physical clinical assessments
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AI SaMD: Cloud hosted software for digital pathology imaging and diagnostics
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AI SaMD: auto-segmentation software for organs at risk for Radiotherapy treatment planning
Physical and Combination Devices
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Electrosurgical cutting devices
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​Ultrasonic surgical devices
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​Photo biomodulation/light therapy devices
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Dental devices
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Acne patches
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Condoms
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Nasal Sprays
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Electronic stethoscope, Mobile app & AI analysis software​
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wearables (for biofeedback data), mobile apps and AI analysis software
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Piezoelectric sensor glove, mobile app and AI analysis software
and many more...
Example Quality Assurance Projects...
CER, Risk management and development process design updates against MDR
​Gap analysis and remediation of QMS against:
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13485:2016 requirements
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MDR requirements
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ISO 14155:2020 Clinical investigation of medical devices for human subjects — Good clinical practice.
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IEC 62304 and IEC 82304 requirements
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ISO 14971 requirements
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ANVISA requirements
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China regulatory standards requirements for AI SaMD
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Creation and development of FDA 21 CFR Part 820, EU MDR and UK MDR compliant QMS
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QMS process design for ISO 13485, ISO 14971, IEC 62304, IEC 82304 IEC 62366, CFR 820, ISO 27001
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Internal and supplier auditing
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Software Development Lifecycle processes remediation
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