Hugo Bertelsen

Hugo Bertelsen Email and Phone Number

CEO at Damkjaer Medical Systems ApS and medicQA A/S @ medicQA A/S
Hugo Bertelsen's Location
North Denmark Region, Denmark, Denmark
Hugo Bertelsen's Contact Details

Hugo Bertelsen work email

Hugo Bertelsen personal email

n/a
About Hugo Bertelsen

Design and development of software to medical equipment manufacturers.Development of Quality Systems for medical and pharmaceutical companies.Listed as inventor on 14 patents.Specialties: Project and people management. Internal and supplier auditor.CMM(i), GxP, GAMP5, 21 CFR 820, 510(k), MDD, MDR, EN ISO standards: 13485, 14971, 62304, 60601.C++, C#/.NET, JavaWindows, Solaris, VxWorks.

Hugo Bertelsen's Current Company Details
medicQA A/S

Medicqa A/S

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CEO at Damkjaer Medical Systems ApS and medicQA A/S
Hugo Bertelsen Work Experience Details
  • Damkjaer Medical Systems Aps
    Chief Executive Officer
    Damkjaer Medical Systems Aps Sep 2022 - Present
    Leading a small, but enthusiastic, team developing medical devices to make this world a better place to live.
  • Medicqa A/S
    Ceo
    Medicqa A/S Jan 2013 - Present
    Aalborg, Nordjylland, Dk
    Leading a team of enthusiastic employees helping medical companies with CE marking their products and establishing the necessary Quality Management Systems to support this activity.Additionally engaged in many projects as a senior advisor. This includes being involved in people and project management as well.Many years of experience with auditing quality management systems and technical files implemented to comply with ISO 13485, ISO 9001, ISO 27001, GxP, and FDA's QSR. In this connection performed a number of supplier audits as well.Conducted numerous audits according to ISO 13485, ISO 27001, and ISO 9001 standards and GxP legislation/guidelines.
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  • Varian Medical Systems Particle Therapy Gmbh
    Sr. Mgmt. Software Engineering
    Varian Medical Systems Particle Therapy Gmbh Jan 2011 - Jan 2013
    Palo Alto, Ca, Us
    Responsible for developing the next generation version of the software for Varian Medical System's ProBeam 2.0 product.Built up and lead an international team of software and software QA Engineers. Grew the software organization from 12 to 82 people and from 1 to 5 development centers in 18 months.Introduced the SCRUM development methodology in the software organization allowing better planning and tracking of resources and finish the 60 Person Year ProBeam 2.0 project on time and within budget.
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  • Hugo Bertelsen Consulting
    Owner
    Hugo Bertelsen Consulting Oct 2007 - Jan 2011
    Development of Quality Systems for medical equipment companies (CE-mark, FDA approval, etc.)Development of software for medical equipment companies.Has performed work for the following companies:1. Varian Medical Systems PT Gmbh: Proton Therapy, Scanning Control System, SW Architect.2. Orbotech Denmark A/S: Small Field of View Gamma Camera, acquisition software, SW Architect/Developer.3. Mermaid Care A/S: Quality Assurance Consultant, ISO 13485, MDD, CE Mark. DS/EN ISO 13485:2003 + AC:2007 certificate received on Apr. 22, 2009.4. Epoka Medic Mission A/S: Quality Assurance Consultant, ISO 13485. DS/EN ISO 13485:2003 + AC:2009 certificate received on Jan. 28, 2010.5.TKS A/S: Quality Assurance Consultant, MDD, CE Mark, ISO 13485.6. Group 4G: Quality Assurance Consultant, MDD, CE Mark.
  • Philips Medical Systems
    Corporate Software Architect
    Philips Medical Systems Apr 1998 - Oct 2007
    Amsterdam, Noord-Holland, Nl
    Design and develop software for gamma camera's (Nuclear Medicine).Project manager on various projects.Architecture for common workstation across Philips Medical Systems.Quality systems.
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  • Adac Laboratories
    Sr. Software Engineer
    Adac Laboratories 1994 - 1998
    Technical leader on a number of projects developing new generations of software for a number of different types of Nuclear Medicine gamma cameras.
  • Adac Laboratories
    Software Engineer
    Adac Laboratories 1989 - 1994
    Developing embedded software for controlling and processing of data from Nuclear Medicine gamma cameras.
  • Cci Europe A/S
    Software Engineer
    Cci Europe A/S 1987 - 1989
    Aarhus, Dk
    Worked as a SW Engineer on adding image processing capabilities to the company's prepress product.
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Hugo Bertelsen Skills

Medical Devices Embedded Software R&d Fda Software Engineering Iso 13485 C++ Product Development Quality Assurance Quality System Project Management Software Development Medical Imaging Management System Architecture Java C# Embedded Systems Testing Software Design Regulatory Affairs Scrum Software Quality Assurance Vxworks Windows Solaris Realtime Embedded Software Development Engineering Management .net Image Processing People Management Ce Marking Dicom Electronics Architecture C Biomedical Engineering Clearcase Firmware Object Oriented Design Algorithms Manufacturing Digital Imaging Robotics Debugging Device Drivers Rtos Signal Processing Hardware Diagnostics Iso

Hugo Bertelsen Education Details

  • Aalborg University
    Aalborg University
    Electrical And Electronics Engineering
  • Holstebro Gymnasium
    Holstebro Gymnasium
  • Ulfborg Byskole
    Ulfborg Byskole

Frequently Asked Questions about Hugo Bertelsen

What company does Hugo Bertelsen work for?

Hugo Bertelsen works for Medicqa A/s

What is Hugo Bertelsen's role at the current company?

Hugo Bertelsen's current role is CEO at Damkjaer Medical Systems ApS and medicQA A/S.

What is Hugo Bertelsen's email address?

Hugo Bertelsen's email address is hu****@****anet.dk

What schools did Hugo Bertelsen attend?

Hugo Bertelsen attended Aalborg University, Holstebro Gymnasium, Ulfborg Byskole.

What skills is Hugo Bertelsen known for?

Hugo Bertelsen has skills like Medical Devices, Embedded Software, R&d, Fda, Software Engineering, Iso 13485, C++, Product Development, Quality Assurance, Quality System, Project Management, Software Development.

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