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Work Background
Consultant In Software Medical Device
Guiding Star Med Tech ConsultConsultant In Software Medical Device
May. 2023RemoteI propose the following services: • Product Development and Scalability Consulting: Guiding design, engineering, manufacturing, and scaling of medical software devices with demonstrated innovation and success. • Strategic Time-to-Market Solutions: Streamlining development and approval processes for expedited product launch, backed by technical and process management expertise. • Regulatory Compliance Consulting: Navigating regulatory processes for market approval with comprehensive support and proven experience. • Quality Management and Post-Market Support: Establishing robust quality management systems and providing post-market support for ongoing product performance and customer satisfaction.
Clinical Product Manager
VisiopharmClinical Product Manager
Apr. 2022 - May. 2023Århus, Middle Jutland, Denmark · Hybrid
Chief Scientific Officer
Brainreader ApSChief Scientific Officer
Oct. 2017 - Apr. 2022Skills: FDA submission · CE marking · Product Management · QMS · FDA
CTO, Co-founder, inventor of the technology behind Brainreader
Brainreader ApSCTO, Co-founder, inventor of the technology behind Brainreader
Jan. 2012 - Oct. 2017Århus Area, DenmarkProduct development Product FDA/CE certification Brainreader ApS develops medical image processing software intended for automatic labelling, visualization and volumetric quantification of segmentable brain structures from magnetic resonance images. Brainreader's main product is the Neuroreader software which provides an estimation of the normal volume for a person with similar demographic data. This is done based on a statistical model and a database of Alzheimers, other types of dementia, and healthy material. Neuroreader is intended to automate the current manual process of identifying, labelling and quantifying the volume of brain structures identified on MR images. Our aim is to establish a support tool for clinicians in the diagnostic process of Alzheimers disease. Neuroreader describes the analysis results in a self-explicative patient report within an analysis-time below one minute. On-going Clinical studies show promising specificity and sensitivity. The Brainreader team is currently working on an FDA and a CE appliance for the system.
Data Consultant
Institute of National Economics of Aarhus School of BusinessData Consultant
Jan. 2010 - Jan. 2012Data manager, responsible of research assistents, responsible of the communication with Statistics Danmark, responsible of submission of new project protocols, helping scientists apply for the data they need for their research by writing the appropriate project description for submission at Statistics Danmark. Datamining
Consultant
Aarhus University HospitalConsultant
Jan. 2008 - Jan. 2012MRI data analysis
Research Assistant
CFIN, Aarhus University Hospital, DenmarkResearch Assistant
Jan. 2005 - May. 2010I learned the techniques involved in neuroimaging that I used later during my PhD.
phd - Neuro-imaging researcher
Center for Psychiatric Research, Århus University , Riiskovphd - Neuro-imaging researcher
Jan. 2005 - Dec. 2009Ph.D. in Medicine
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