Business founder, Dr Keith Morris is a registered Member of The Organisation for Professionals in Regulatory Affairs (TOPRA) and holds professional qualifications in Marketing (Chartered Institute of Marketing) and Company Management (Institute of Directors). He also holds a PhD in Biochemistry from the University of Birmingham and a BSc (Hons) in Chemistry with Biochemistry from the University of Leicester
He holds over 20 years’ experience in the medical technology industry that includes
- Developing sterile and non-sterile single use medical devices under an ISO13485 Quality Management System, managing the preparation of technical files for these products and attending audits by Notified Bodies.
- Leading a start-up medical device company through product development of a class IIa medical electrical device, regulatory approval and clinical trials and onto the market.
- Preparing Technical files for start-up and SMEs with devices ranging from in-vitro diagnostic devices to health-apps and guiding them through registration.
- Preparing Quality Management Systems required by the Medical Devices Directive