Supply chain, manufacture, quality systems and certification

IoT Home Intruder Alarm System

• Supply chain development and implementation in China.
• Distribution.
• Supply and quality contracts.
• Achieved ISO 9001 certification after hosting two independent audits.
• Launch and scale.
• Developed cost of goods model.
• Implemented supplier KPIs.

COVID Test Device and Strip

• Wrote ISO 13485 quality system for IVD CE certification.
• Created technical file.
• Supplier evaluation and commercial and quality agreements.
• Pasted ISO phase I audit. 
• Developed production verification and validation protocols for electronics.
• Prepared QMS from change from IVDD to IVDR.

IoT Health System for Carehomes

• Evaluated and qualified manufacturing partner in Lithuania.
• Implemented batch controls and release processes. 
• Implemented quality system and contracts.
• Created distribution process.
• Low cost sourcing of wireless charger.
• Developed regulatory framework for ongoing compliance to CE and UKCA.

High Performance Wheelchair.

• Established regulatory pathway.
• Developed and wrote quality management systems.
• Supported improved controls in production and quality assurance.

Novel Vaccine for Encephalitis

• Evaluated and validated global supply chain including for the US Military.
• Hosted MHRA and FDA and passed critical inspections.
• Validated global cold chain logistics.
• Launched product and expanded to several new markets around the world.

Solar Powered Lighting Products (mainly for use in Africa)

• Supported the team to follow the correct regulatory pathway and product approval.
• Created framework for team to maintain compliance through new processes.
• Benchmarked the manufacturing cost to ensure current cost were in line.

Novel Dental Caries Diagnosis System

• Evaluated and validated supply base.
• Passed FDA audits and achieved certification.
• Created cost model and strategy to deliver significant savings over time.
• Implemented kitting and fulfilment to US market from the UK

Worlds First Congestive Heart Failure Diagnostic system.

• Developed supply chain and secured supplies to scale production.
• Achieved cost reductions.
• Managed several new market pilots and supported clinical evaluations.

Worlds First Single Use Contact Lens

• Sourced and setup warehousing facility 14,00 sq ft.
• Achieved significant cost savings via negotiations and managing buyers.
• Launched several new products around the world.
• Oversaw £50m capital expansion of production and kitting and managed negotiations.
• Passed all regulatory inspections including FDA.