Medical Device Consultant

In more than 20 years of engineering and management in the field of medical devices (Neurostimulation, active medical implants), I was able to gain expertise in Research & Development, Quality Management, Regulatory Affairs, Project Management and Upper Management.

About me

I started as an engineer developing devices for Neurostimulation and took over project management for various stimulation and biofeedback devices at Otto Bock Healthcare Products GmbH. Heading the Neurostimulation department I was not only confronted with development but also with structural and strategic challenges as well as with product certification approval. As CEO of Neurodan A/S I spent two years in Denmark leading about 50 employees to get the implant system for dropfoot ready for market and to inhouse the implant production. As Vice President Operations of the Neurostimulation Business Unit, I was responsible for the technical matters of Neurostream Technologies Inc. (Quebec), Neurodan A/S (Denmark) and Otto Bock Healthcare Products Gmbh (Austria), focusing on product synergies. For the product transfer of the implant system ActiGait® between two subsidiaries with different Quality Management Systems, I was responsible for the establishment of the R&D department and the according Design Control processes at nstimServices GmbH.

Professional Expertise

My professional expertise covers the topics

  • R&D / Product Development of Medical Devices (incl. Active Implants)
  • Design Control
  • Safety and Essential Performance
  • Risk Management
  • Usability
  • Verification & Validation
  • Design Transfer
  • Technical File, Design History File (DHF), Design Dossier
  • Medical Device Standards: IEC 13485, IEC 60601 -1, IEC 60601-1-11, IEC 60601-1-2, IEC 62366, IEC 14971, IEC 60601-2-10, ISO 14708-1, ISO 14708-3
  • Medical Device Regulation (MDR)
  • Project Management
  • Managing an R&D group
  • Leadership of Management Team
  • Coordination of Clinical Partners
  • Product Transfer

Services

Case studies where I can support you

  • You are a start-up company in the medical device industry and need to establish the Quality Management processes for Design Control.
  • Your next product generation will enter the field of active implantable medical devices and you need guidance/support in Risk Management or V&V activities.
  • You are limited in resources and need support in establishing the DHF, Design Dossier.
  • You develop the next product generation and have to ensure that the design is compliant with the actual medical device standards.
  • Your project is late in time and you need project expertise and execution or a sparing partner for one of your team members.
  • You need a coordinator for your clinical partners.

Projects

(as member of the Otto Bock group)

8 Channel System for Standing and Walking of Paraplegics

In cooperation with the Center of Physics and Biomedical Engineering of the Medical Unsiversity in Vienna and the Ludwig Bolzmann Institut für Elektrostimulation and Physikalische Rehabilitation we developed a stimulation system for the mobilization of paraplegics and conducted a Clinical Study according ISO 14155. My responsibility was part of the electronic and embedded software development and technical support at the patient training site.

STIWELLmed4

As part of a joint venture with MEDEL we developed a 4 channel stimulation and biofeedeback system for rehabilitation of patients following a stroke, spinal cord injury, plexus parese, and other diseases with impact on the muscle-nerv system. As Project Manager I was responsible for the product development, establishment of the Design History File and the coordination of the clinical partners.

MyGait®

As Project Manager and Head of the Neurostimulation R&D department I was responsible for the concept of the surface stimulator for drop foot, the research funding proposal and the development of the first functional prototype.

ActiGait®

ActiGait® is an implantable system for foot drop correction after stroke. Together with the management team I was as CEO of Neurodan A/S responsible for the redesign to get the product ready for market and for the inhousing of the implant production site. As Director of R&D at nstim Services GmbH I was responsible for the product transfer and the establishment of the Design Control and DHF.

Education and Training

  • 1998

    Ph.D. Degree

    Theses: Functional Electrical Stimulation of Upper Extremity

  • 1985 – 1992

    Studies of Industrial Electronics and Control Engineering

    University of Techn. Vienna, Focus on Biomedical Engineering

Employment / Professional Experience

  • since 2017

    Consultant

    (References on request)

  • 2014 – 2016

    Director of R&D, nstim Services GmbH (member of Otto Bock group), Vienna

    Establishment of the R&D department and Design Control for active medical implants
    Responsibility for the R&D Transfer of ActiGait® from Neurodan A/S to nstim Services GmbH

  • 2012 – 2013

    Vice President Operations, Business Unit Neurostimulation of Otto Bock, Vienna

    Responsibility for technical Neurostimulation issues at Neurodan A/S (Denmark), NeuroStream Technologies Inc.(Quebec), and Otto Bock Healthcare Products (Vienna)

  • 2010 – 2012

    CEO of Neurodan A/S (member of Otto Bock group), Aalborg, Denmark

    Redesign and readiness for marketing of ActiGait® (implant system for drop foot)
    Inhousing of implant production for ActiGait®

  • 2007 – 2010

    Head of R&D/Neurostimulation Department, Otto Bock Healthcare Products GmbH, Vienna

    Project management of MyGait® project (2 channel stimulation system for drop foot)

  • 2000 – 2007

    Project Manager, Otto Bock Healthcare Products GmbH

    Product development of STIWELLmed4 device (Joint Venture with MEDEL, Innsbruck)

    Development Engineer, Otto Bock Healthcare Products GmbH, Vienna

    8 Channel System for Standing and Walking of Paraplegics (coop. with BMTP, Vienna)

  • 1995 – 1999

    Research/Postgraduate Research Assistant, Centre for Biomed. Engin. & Physics, Vienna

  • 1993 – 1994

    Medical Instrumentation Engineer, R&D Department of AVL List GmbH, Graz

Publications

(extraction)

Rakoš M., Freudenschuß B., Girsch W., Hofer C., Kaus J., Mayr W., Meiners T., Paternostro T.: EMG-getriggerte FES der Arm-und Handmuskulatur: bisherige Ergebnisse einer Patientenstudie, Österr. Z.Phys.Med.Rehabil. 7/Supplement 2, 69-72, ISSN: 1026-079X, 1997

Rakoš M., Freudenschuß B., Girsch W., Hofer C., Kaus J., Mayr W., Meiners T., Paternostro T.: FES unterstütztes Myofeedbacktraining von Muskeln der oberen Extremität, Biomedizinische Technik 43/Ergänzungsband 2, 125-127, ISSN: 0939-4990, 1998

Rakoš M., Freudenschuß B., Girsch W., Hofer C., Kaus J., Meiners T., Paternostro T.,Mayr W.: Electromyogram-controlled functional electrical stimulation for treatment of the paralyzed upper extremity, Artificial Organs 23(5), 466-469, ISSN 0160-564X, 1999

Rakoš, M., Bijak, M., and Hofer, C. Anwendungen der Funktionellen Elektrostimulation(FES) im Bereich der Bewegungsrehabilitation. Orthopädie Technik 09/04. ISSN 0340-5591

Rakoš, M., Bijak, M., Hofer, C., Mayr, W., Unger, E., and Kern, H. Eight channel stimulation system for mobilization of paraplegic patients. J REHABIL RES DEV 2004;41:58-58.

Rakoš, M., Bijak, M., and Hofer, C. Mobilisierung paraplegischer Patienten mit Hilfe Funktioneller Elektrostimulation (FES). Orthopädie Technik 2/05: 104-105. ISSN 0340-5591

Rakoš, M., and Auer M.: Bewegungsrehabilitation mithilfe EMG-getriggerter Elektrostimulation. Orthopädie Technik 2/10: 94-97. ISSN 0340-5591

Contact

DI Dr. Monika Rakoš
Haizingergasse 52/5
A-1180 Vienna, Austria

monika@rakos-consulting.com
+43 (0)660 5520121

Imprint

Sparte Gewerbe und Handwerk
Fachgruppe LI Mechatroniker
Berufszweig Mechatroniker für Medizingerätetechnik
Ausstellende Behörde MBA 18
UID ATU71986014

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