Gustav Hoppe Email & Phone Number

Sweden

Stockholm, Sweden

• Member of SEK TK-62 Medical equipment, software, and systems
• Regulatory Strategy for Medical Devices and IVD Instruments for Market Access.
• Technical File for IVDR and MDR
• FDA Submissions, Health Canada and other submissions.
• Compliance Analysis for Software, Usability, Risk Management, Cybersecurity.
• Construction review of Medical Devices and IVD instruments per applicable standards.

Stockholm, Sweden

• Software as a Medical Device (SaMD). Treatment Planning System for radiation therapy.
• Responsible for all Submission to North- and South America including FDA, Health Canada, ANVISA (Brazil), INVIMA (Colombia), etc
• FDA Pre-Submission (Q Submission) proposing a framework around Machine Learning Algorithm per FDA guidelines.
• Vigilance Reporting, Field Safety Notice, Recalls, Incident Reporting.

Copenhagen, Denmark

• Regional Technical Lead for Usability (IEC 62366)
• Representative in SEK TK62 for Medical Devices.
• Same as below

Chicago, USA

• Medical Device: Reviewer and Handler of safety compliance evaluations of Medical Devices, IVD instruments and similar devices per IEC 60601-1, Particular standards and National Deviations, including review of Risk.
• Nurse Call Systems: Review and Handle safety compliance evaluations of Nurse and Emergency Call Systems per UL 1069, UL 2560, CSA No 205 and CSA No 60601-1, including both wired and wireless systems.
• Laboratory Equipment: Reviewer and Handler of safety evaluations of Measurement-, Control-, and Laboratory Equipment per IEC 61010-1, Particular standards and National Deviations.
• Working closely with customers preparing UL Reports, CB Reports for Global Market Access.

Stockholm, Sweden

• Multigas Analyzer for integration in Patient Monitoring System
• Responsible for all international certifications such as Technical File for CE Marking per MDD (European Medical Device Directive), 510k Applications to FDA for sales clearance to the USA.
• Responsible for maintaining Requirement Specifications (including regulatory-, market-, and technical requirements), Test Specifications, Requirement Traceability and Risk Management File.
• Planning Verification and Validation activities necessary to show compliance with applicable standards such as IEC 60601 (Medical Equipment), ISO 21647 (Respiratory Gas Monitors) and EN1789 (Road Ambulances).

Stockholm, Sweden

• Embedded SW Engineer, Siemens Medical Solutions, Digital Mammography System, 2002 – 2004
• R&D Engineer, Proximion Fiber Optics, Fiber Optic Communication Link Device, 2002
• R&D Engineer, Medicinal Laboratory Instrument, Personal Chemistry, 1999 – 2002
• R&D Engineer, Aerocrine, Asthma Detection Device, 1999

Umeå, Västerbotten, Sweden

Developed and implemented a SW algorithm in MatLab to automatically identify and separate different types of textures present in a mammogram into anatomical zones, using Image Analysis and a Neural Network. Publications:1. F. Georgsson and G. Hoppe, On the problem of tissue classification in mammograms in H.U. Lemke, M.W. Vannier, K. Inamara, A.G. Farman.

Master Of Science, Engineering Physics

Bachelor Of Science, Electronics And Computers