Our Team

DI(FH) Dr. Michael Ring

Clinical evaluation, Clinical trials of medical devices (EN 14155), Performance evaluation of IVDs

Michael Ring

I interpret my role as a consultant as a long-term cooperation with companies in the implementation of ideas in the fascinating field of medical technology. With my broad expertise and my professional network I am at your disposal to jointly master the diverse challenges of this field.

My professional passions include the clinical investigation of medical devices and the performance evaluation of IVDs.

Work experience

  • Manager von klinischen Studien am Kepler-Universitätsklinikum (Augenklinik)
  • Trainertätigkeit, Quality Austria
  • FH OÖ Forschungs & Entwicklungs GmbH, Linz (Österreich) Medizintechnik, Wissenschaftlicher Angestellter
  • Nebenberuflich Lehrbeauftragter Fachhochschule Oberösterreich, Studienrichtung Medizintechnik - Software Lifecycle Processes
  • Hertie Institut für klinische Hirnforschung, Tübingen
  • Smith Kettlewell Eye Research Institute, San Francisco

Professional qualifications

  • Quality Austria - Medizinprodukte Entwicklung/Herstellung/Vertrieb
  • CPMS - Certified Professional for Medical Software
  • GCP Update - Durchführung Klinischer Studien in Österreich
  • TÜV Süd Akademie - Grundkurs Medizinprodukterecht
  • TÜV Süd Akademie - Managementsysteme für Hersteller von Medizinprodukten
  • TÜV Süd Akademie - Risikomanagement für Medizinprodukte nach der DIN EN ISO 14971
  • TÜV Süd Akademie - Anforderungen an Zulieferer in der Medizintechnik
  • TÜV Süd Akademie - Technische Dokumentation für Medizinprodukte
  • Quality Austria - Workshop Qualitätsmanagement, Medizinprodukte
  • Quality Austria - Workshop Produktdokumentation, Medizinprodukte
  • Quality Austria - Prozessanalysen, Medizinprodukte

Education

  • PMU – Paracelsus Medical Private University, Salzburg, Doctorate in Medical Science
  • FH Upper Austria, Linz, Medical Engineering


michael.ring@rnb-consulting.at

DI(FH) Dr. Andreas Böhler, MLBT

Medical Software (EN 62304, EN 62366, IEC 82304-1), Quality Management (EN ISO 13485), Mobile Health (EN 62304, IEC 82304-1), Audits (according to EN ISO 19011)

Andreas Böhler

Open source software and hardware related programming have always been my favorite topics. To develop a medical device in one of these areas requires experience and expertise beyond mere technology. For the realization of projects I support you with my special knowledge, from the idea to the finished product up to the market surveillance.


Work experience

  • Nebenberuflich Lehrbeauftragter Fachhochschule Oberösterreich - Software Lifecycle Processes / Betriebssysteme & IT-Sicherheit
  • Entwicklungsingenieur GE Healthcare, Zipf
  • Freier Software-Entwickler medPhoton GmbH, Salzburg
  • Wissenschaftlicher Mitarbeiter & Betreuung QM-System radART Institut der Paracelsus Medizinischen Privatuniversität Salzburg
  • EDV Betreuung Ordination für Allgemeinmedizin
  • Universitá degli studi di Pavia, Pavia, Italien

Professional qualifications

  • gmds - Zertifikat Medizinische Informatik
  • bsi Akademie - Lead Auditor EN ISO 13485:2016
  • Linux Professional Institute - LPIC-2
  • Linux Professional Institute - LPIC-1
  • TÜV Austria - Zertifizierter Medizinprodukteberater
  • TÜV Austria - Datenschutzbeauftragter

Education

  • JKU - Johannes-Kepler-Universität, Linz, Recht und Wirtschaft für Techniker
  • PMU - Paracelsus Medizinische Privatuniversität, Salzburg, Doktorat der medizinischen Wissenschaften
  • FH Oberösterreich, Linz, Studiengang Medizintechnik


andreas.boehler@rnb-consulting.at

Ing. Andreas Aichinger, MSc

Production and clean room, sterile processes, ISO 13485

Andreas Aichinger

Due to my many years of experience as a quality manager at an international medical device manufacturer and my work as a trainer and auditor, I know the normative and legal requirements as well as practical ways of implementing external requirements correctly and efficiently. My main competences are sterilization processes and clean rooms, the implementation of quality requirements in production, validation and the development of management systems according to ISO 13485.

Work experience

  • Chemotechniker (DSM Fine Chemicals Austria) - Pharma
  • Qualitätsbeauftragter (DSM Fine Chemicals Austria)- Pharma
  • Branchenbeauftragter Medizinprodukte (Quality Austria) - Zertifizierung / Auditierung
  • Trainer bei Quality Austria im Bereich Medizinprodukte
  • Mitglied im österreichischen Normungsausschuß (Arbeitsgruppe: Medizintechnik/Medizinprodukte)
  • Mitglied in der ISO Normung ISO/TC76 – “Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use

Professional qualifications

  • Auditorenausbildung ISO9001, ISO13485, DQS MED (benannte Stelle)
  • Europa + USA: Zulassung / Zertifizierung von Medizinprodukten, Forum Institut
  • Jährliches Medizinprodukte Update, Forum Institut
  • Auditorenschulung laufend, DQS MED
  • Gutachterausbildung Techn. Dokumentation / Hauptaktenprüfung Medizinprodukte, DQS MED
  • Auditorenausbildung durch Health Canada (CMDCAS-Programm) für eingetragene Registrars, Academia Qualitas
  • Good Clinical Practice (GCP) für Medizinprodukte

Education

  • Höhere Technische Bundeslehranstalt für Chemieingenieurwesen und Chemieverfahrenstechniker (HTL Ing.)
  • Aufbaulehrgang Umweltmanagement und technischen Umweltschutz
  • Masterstudium “Executive Management mit Schwerpunkt Quality Management”


andreas.aichinger@rnb-consulting.at

Cornelia Hoflehner, BSc

Project Management, Usability Engineering, IVDR, MDR

Cornelia Hoflehner

The medical technology sector is constantly expanding and it is becoming more and more difficult to keep track of the documentation and guidelines required for the individual products in order to obtain the necessary certifications.

I see it as my mission to support the companies on this complex path.



Work experience

  • Praktikum Stratec Consumables GmbH (3 Monate)

Education

  • Derzeit: Recht und Wirtschaft für Techniker (Master)
  • FH OÖ, Campus Linz, Bachelorstudiengang Medizintechnik
  • HLW für Mediendesign und Kommunikation Linz


cornelia.hoflehner@rnb-consulting.at
+43 (0)677 62947328

DI Melanie Baumgartner, BSc

Project Management, Usability Engineering(EN 62366), Medical IT networks (IEC 80001-1), MDR

Melanie Baumgartner

The constantly growing degree of innovation in medical technology involves not only positive aspects such as easier work for doctors and improved quality of life for patients, but unfortunately also high risks. Therefore, I see it as my duty to support companies in the medical technology sector in the development of their products.

My main professional focus is on the one hand usability engineering in order to optimally implement the user-product interface and on the other hand IT risk management in order to analyze and manage the risks of connecting medical devices to the medical IT network of a hospital. As RnB project manager it is my duty to lead the entire project team and to always keep it up to date on the basis of clearly arranged and visually designed weekly reports.

Work experience

  • Nebenberuflich Lehrbeauftragte Fachhochschule Oberösterreich - Projektmanagement und Risikoanalyse
  • Beraterin Systematisches Risikomanagement mit Hauptaugenmerk auf IT-Risikoamangement nach ISO/IEC 80001-1, Calpana Businessconsulting

Professional qualifications

  • SANITAS - Zertifizierung “IEC 80001-1 Risikomanagement für IT-Netzwerke mit Medizinprodukten”
  • Calpana - Zertifizierung CRISAM® Beraterin
  • Calpana - Zertifizierung CRISAM® Trainerin
  • AUVA - Zertifizierung zur Laserschutzbeauftragten (LSB)

Education

  • FH Oberösterreich, Linz, Studiengang Medizintechnik


melanie.baumgartner@rnb-consulting.at
+43 677 6122 89 67

Bernhard Schwartz, BSc MSc

Biostatistics , study planning, study implementation, study evaluation

Bernhard Schwartz



In science, insignificant seeming decisions in project planning can lead to enormous problems in the project's later stages. Careful planning of the study design, including all the subsequent steps, including statistical evaluation, is essential for the success of the project. As a consultant and active scientist, it is my goal to support and accompany clients in the best possible way in the planning and evaluation of studies.






Work experience

  • Universität Wien & FH Oberösterreich, Nebenberuflich Lehrbeauftragter, Biomechanik & Sportinformatik
  • FH OÖ Forschungs & Entwicklungs GmbH, Wissenschaftlicher Angestellter & Studienleiter, Medizintechnik & Ergonomie
  • Seibersdorf Labor GmbH, Studienleiter, Inhalationstoxikologie
  • Royal Melbourne Institute of Technology, Melbourne/Australien, Gastforscher, Biomechanik

Professional qualifications

  • Kapsch Award
  • Science Slam Gewinner

Education

  • Universität Wien, Wien, Doktorat der Naturwissenschaften
  • FH Technikum Wien, Wien, Gesundheits- und Rehabilitationstechnik
  • FH Technikum Wien, Wien, Sportgerätebau


bernhard.schwartz@univie.ac.at
+43 (0)680 311 69 22

Dr. Stefan Lahnsteiner

Medical Devices Act (MPG), Data Protection Act

Stefan Lahnsteiner


As a lawyer, lecturer and author on legal topics, I have the necessary legal competence to provide advice on questions of medical law (liability, medical product law, etc.) due to my work as a lawyer, lecturer and author. I am also happy to handle the preparation of the necessary contracts, for example in the context of clinical trials.

Work experience

  • Selbstständig tätiger Rechtsanwalt (Ebensee)
  • Laufende Vortragstätigkeit (WIFI, Österreichische Gesellschaft für Versicherungsfachwissen…)
  • Rechtsanwaltsanwärter bei Landl + Edelmann Rechtsanwaltspartnerschaft, Vöcklabruck
  • Gerichtspraxis BG und LG Salzburg
  • Univ.-Ass. an der Universität Linz, Institut für Multimediale Linzer Rechtsstudien, Abteilung für Multimediales Zivilrecht; Lehrtätigkeit AG und Rep Bürgerliches Recht

Professional qualifications

  • Insurance Award Brain 2013 des Instituts für Versicherungswirtschaft, Universität Linz
  • Wolf Theiss Award
  • Förderpreis der Gesellschaft für Versicherungsfachwissen
  • Förderpreis D.A.S.
  • Auszeichnung Excellent Talents, Studienvertretung Rechtswissenschaften, Universität Salzburg

Education

  • Absolvierung der Rechtsanwaltsprüfung
  • JKU - Johannes Kepler Universität, Linz, Doktoratsstudium der Rechtswissenschaften
  • PLUS - Paris Lodron Universität, Salzburg, Diplomstudium der Rechtswissenschaften


www.anwalt-lahnsteiner.at
kanzlei@anwalt-lahnsteiner.at
+43 6133 5354-14





DI Martin Schmid

Regulatory Compliance, Quality Management for Medical Device Manufacturers

Martin Schmid

Martin Schmid has been Managing Director and Senior Consultant of en.co.tec Schmid KG, Engineering & Management Consultancy for Development, Approval and Quality Management for Medical Devices in Vienna since 2000.

He has extensive regulatory and technology experience in the field of active and inactive medical devices and in-vitro diagnostics in the field of regulatory compliance and quality management for medical device manufacturers.

For many years he has been lecturer / trainer at numerous en.co.tec seminars and en.co.tec in-house trainings, at the universities of applied sciences Upper Austria and Wiener Neustadt, at the Danube University Krems and all Austrian medical technology clusters.

He is a member of the CMI (Regulatory Compliance Initiative of the Federal Ministry of Health / Department of Medical Devices) as well as of international standardization committees.

Mag. pharm. Dr. Theodor Langer, MScTox, PMP

Biocompatibility (EN 10993), Toxicity (EN 10993)

Theodor Langer

As a consultant, I support my clients taking into account holistic and sustainable aspects. Not only the technical side, but also the efficient team structure and team development are central components of the order processing. Each client has a specific problem, therefore the developed solutions are individual. The projects are implemented in the shortest possible time, using resources efficiently and achieving the agreed quality goals.


Work experience

  • Gründer von Tikopia Consulting
  • Studiengangsleiter Regulatory Affairs am IMC Krems
  • Projektleiter für globale Entwicklungsprojekte bei Baxter
  • Universitätsassistent an der VMU, Wien
  • Apotheker in öffentlichen Apotheken

Professional qualifications

  • Project Management Professional, PMI
  • Senior Project Managmenet, MCE
  • Leadership Training, CCL
  • Scientific Advice Training, PTI
  • Biologics Drug Development, PERI

Education

  • Master of Science, Toxicology, Universität Wien
  • Doktor der Naturwissenschaften, Universität Wien
  • Magister der Pharmazie, Universität Wien

www.tikopia-consult.at
theodor.langer@tikopia-consult.at
+43 660 49 55 780

Mag. Dr. Birgit Spitzer-Sonnleitner

IVD, Analytics, Pharmaceuticals

Birgit Spitzer-Sonnleitner


With many years of experience in various areas of the pharmaceutical industry, including quality assurance, quality control and internal as well as external audits of individual areas, I am able to comprehensively identify requirements and integrate solutions tailored to customer needs. The integration of the systems and the necessary knowledge in the companies is carried out under special consideration of the regulatory requirements.

Within the scope of my consulting activities for companies, I try to establish not only the implementation of the required systems, but also the knowledge within the company.

Work experience

  • Nebenberufliche Lehrbeauftragte IMC Krems (Qualitätsmanagment), FH Wels (Qualitätssicherung im Labor)
  • Auditor (GMP Schwerpunkt API)
  • Qualitätssicherung mit Schwerpunkt Lieferantenmanagement, Auditmanagement Baxter, Nycomed
  • Laborleiter Qualitätskontrolle Baxter

Professional qualifications

  • Berechtigung zur Ausübung der Funktion der Sachkundigen Person
  • APIC certified Auditor
  • Lehrgang Klinische Studien an der PMU Paracelsus Medizinische Privatuniversität Salzburg
  • Quality Austria Systemmanager Qualität

Education

  • Doktorat Chemie mit Schwerpunkt Analytische Chemie, Universität Wien

www.tikopia-consult.at
birgit.spitzer-sonnleitner@tikopia-consult.at

Ing. Florian Brunner, MSc

Information Security, Penetration Testing/Hacking, Network and Application Security

Florian Brunner


I was the founder and owner of the Austrian consulting company Holistic Security Consulting with focus on security audits, security consulting and support of security-critical projects. Since 2017 I have been working as a security consultant for the VACE Group. For several years I have been working as a consultant for DAX companies and have been regularly confronted with the challenges of information security. In addition to current topics such as industry 4.0, I also deal with legacy systems, the processing of security incidents and penetration testing.

As a consultant on information security, it is very essential to consider the topic of security in the medical environment. The protection of data processed in the medical product sector is an important issue and data security must be a central aspect.

Work experience

  • Mitgründer von Awarity Training Solutions GmbH
  • Mitgründer und Managing Director, Holistic Security Consulting GmbH
  • Nebenberuflicher Lehrbeauftragter, FH OÖ StudienbetriebsgmbH
  • Berater/Wissenschaftlicher Mitarbeiter, FH OÖ F&E GmbH
  • Software Engineer, Industrie Informatik GmbH

Professional qualifications

  • Certified Ethical Hacker, CEHv8
  • ISO 27001 Training
  • Oracle Security

Education

  • FH OÖ, Campus Hagenberg, MSc BSc
  • HTBLA Leonding, Schwerpunkt EDV und Organisation, Ing.

florian.brunner@vace.at
+43 (0) 732 272277 51

Erik Rusek, MSc

Information Security, ISO/IEC 27001, EU-DSGVO, Audit, Awareness, EN 80001-1

Erik Rusek


In 2013 I founded the Holistic Security Consulting GmbH together with my partner and in 2014 the second company Awarity followed. Since 2017 I have been working as a security consultant for the VACE Group. My main tasks include penetration testing, social engineering, security awareness, organizational information security and the related standards (ISO/IEC 27001, EU-DSGVO, BSI-Grundschutz). Information security and data protection must be viewed holistically in an organisation and combine the topics of organisational structures, processes, IT and law.

Therefore it is particularly important that we define and implement security and data protection standards together with our customers, which are optimally adapted to the requirements of our customers and take the overall solution into consideration.

Work experience

  • Mitgründer von Awarity Training Solutions GmbH
  • Mitgründer und Managing Director, Holistic Security Consulting GmbH
  • Risk Consulting, KPMG Linz
  • Risk Consulting, KPMG Köln
  • Software-Engineer, RACON Software GmbH

Professional qualifications

  • Certified Ethical Hacker, CEHv8
  • ISO 27001 Auditor

Education

  • FH OÖ, Campus Hagenberg, MSc BSc
  • HTBLA Leonding, Schwerpunkt EDV und Organisation, Ing.

erik.rusek@vace.at
+43 (0) 732 272277 52

DI Andreas Parzer

Safety and essential performance characteristics of medical electrical devices and systems (EN 60601), Safety of laboratory equipment (EN 61010), Approval of medical devices (Directive 93/42/EEC), Quality management systems for medical devices (EN ISO 13485)

Andreas Parzer

During almost 30 years of working in an accredited testing laboratory for medical electrical devices and electrical laboratory devices I was able to gain a lot of experience regarding the safety requirements and essential performance features of medical and laboratory devices. My many years of experience as a leading auditor and certification officer at a notified body for medical devices are an essential qualification for the comprehensive support of customers within the scope of approval procedures and certifications.

Work experience

  • Leitung der autorisierten bzw. (später) akkreditierten Prüfstelle für Medizinprodukte der TÜV AUSTRIA SERVICES GMBH
  • Planung eines Prüflabors bei VAMED-MSG
  • Zertifizierungsbeauftragter und leitender Auditor der benannten Prüfstelle des TÜV AUSTRIA
  • Referent bei verschiedenen Veranstaltern zum Thema Sicherheit medizinischer elektrischer Geräte und QM-Systemen für Medizinprodukte

Professional qualifications

  • Lead-Auditor EN ISO 9001, EN ISO 13485, Auditor RL 93/42/EWG
  • Ausbildung zum Laserschutzbeauftragten (AUVA)
  • Mitglied des Technischen Komitees OVE TK “Medizinprodukte”
  • Mitglied der internationalen Arbeitsgruppen IEC SC62A / WG14 (IEC 60601-1) und CTL-ETF3
  • Kompetenz in der Ermittlung von Messunsicherheiten

Education

  • Studium Elektrotechnik / industrielle Elektronik an der Technischen Universität Wien

andreas.parzer@a1.net
+43 (0) 664 52 62 376





Marion Krejci, MAS, MBA

Hygiene management, hygienic reprocessing of medical products, hygiene design


Marion Krjeci

Since September 2013 I have been managing partner of HYGline GesmbH hygiene issues & management. I can apply my decades of experience as a practitioner and develop new projects. I am particularly proud of the unique development of the HYGline database. It enables the customer to access his hygiene-relevant data quickly and clearly. For him, this means a decisive “more” security for his hygiene management as well as the continuous improvement of hygiene standards in medical facilities. The EICHY material compatibility database was created on the initiative of HYGline. EICHY (European Interdisciplinary Committee for Hygiene & Compatibility Testing of Medical Devices) offers an electronic platform that provides interested parties with free information on the correct hygienic preparation of medical devices. The platform is aimed primarily at medical professionals and manufacturers of medical devices.

Work experience

  • Geschäftsführende Gesellschafterin - HYGline GmbH hygiene isssues & management
  • Prokuristin, gewerberechtliche Geschäftsführerin für Medizinprodukte Antiseptica-Austria chemische- pharmazeutische Produkte GmbH
  • Repräsentantin - F. Joh. Kwizda GesmbH Pharmazeutischer Vollgroßhandel
  • Key Account Management Ost/Österreich, Produkt- und Projektmanagement bei Henkel Hygiene Produkte (später Henkel-Ecolab)
  • DGKP, Hygienefachkraft

Professional qualifications

  • Sonderausbildung in der Krankenhaushygiene
  • Lehrgang für Marketing-Management

Education

  • Professional Master of Business Administration in Change Management - MBA
  • Business Management MAS Universität Klagenfurt
  • Certified Risk ManagerIn
  • DGKP

marion.krejci@hygline.at

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