Dave Arrowsmith Email & Phone Number

Oxford, GB

Oxford, United Kingdom

- Led successful FDA 510(k) submission, EU MDR application and DCB 0129 compliance.- Co-author of MDR clinical evaluation report (CER) and technical file.- Led post-market surveillance and post-market clinical follow-up.- ISO 13485 certified Quality Management System implementation and maintenance, including technical administration of Optellum’s Atlassian.

Oxford, United Kingdom

- Designed processes for Agile software development compliance with applicable medical device standards.- Authored procedures to achieve Optellum’s initial ISO 13485 certification.- Planned and executed automated web application testing (Selenium with Scala).

Oxford, United Kingdom

- Led requirements gathering, use case to system requirement and design specifications for Mirada's first interventional radiology application, Simplicit90Y.- Led testing of Mirada’s core diagnostic imaging solutions.- Mentored and coached product analysts and test engineers.- Software as a medical device (SaMD), ISO 13485, ISO 14971, IEC 62304.

Banbury, UK

Updated testing processes in the Business Change function, improving software quality by managing, planning and executing multi-level testing. Led a change in testing strategy for the organisation’s £20m Transformation programme.

Banbury, UK

iSoft built software for healthcare providers worldwide. Successfully managed system testing, coordinating offshore development, testing and support teams – resulting in marked improvements in software quality. Designed, executed and documented testing for numerous legacy and modern healthcare development projects.

Timaru, New Zealand

Carried out requirements analysis with key stakeholders for a NZ$3 million project to replace core clinical and healthcare systems.Managed a project to satisfy national mental health reporting requirements, including design and development of a data warehouse. First organisation to achieve compliance.

Kettering, UK

Designed, developed, tested and supported bespoke business web applications.

Bracknell, England, United Kingdom

Plant molecular biology research.

Bedford

Carried out research into fruit ripening and plant cell walls. Published in peer-reviewed scientific journals and patents, and presented at international conferences.