Requirements Management For Regulated Products

“…brilliant to work with, knowledgeable in diagnostics and science broadly. A great work ethic. Positive, collaborative and fun to work with too”

“We enlisted the expertise of Upstart Bio/Matt in updating our new product development processes to align with the evolving needs of our business whilst maintaining compliance with ISO13485. His knowledge and practical approach proved invaluable as he helped us develop a streamlined system that enhanced efficiency across the organization. The new framework has laid a robust foundation for future development of our IVD products”. “Matt's/ Upstart Bio's Project Management skills have been incredibly helpful, when we required experienced short-notice resource he quickly understood project needs, ensured a collaborative and consistent approach across the multidisciplinary teams and successfully executed several projects.”

“My company required project management activities for a CE-marked IVD device. The process was complex and, despite joining us mid-project, I was impressed and reassured by Matt’s ability to grasp the essential details of the project from the get-go. He managed and corralled the various modalities within in the project to achieve a very successful outcome, bringing the project within budget and on time”

“…thorough, well organised approach … pivotal in ensuring smooth delivery of the project  which was centred on the IVD market [a £2.1M Biomedical Catalyst project]”