Our Team

DI(FH) Dr. Michael Ring

Clinical Evaluation, Clinical investigation of medical devices (EN ISO 14155), Medical Software (EN 62304)

Michael Ring

Professional Experience

  • Manager of clinical trials at the Kepler-University clinic, Linz, Austria
  • Trainer, Quality Austria
  • FH OÖ Forschungs & Entwicklungs GmbH, Linz (Österreich) Medical Engineering, Scientific staff
  • Lecturer, Fachhochschule Oberösterreich, Medical Engineering - Software Lifecycle Processes
  • Hertie Institut for clinical brain research, Tübingen
  • Smith Kettlewell Eye Research Institute, San Francisco

Qualifications

  • CPMS - Certified Professional for Medical Software
  • GCP Update - Clinical trials in Austria
  • TÜV Süd Akademie - Basics in medical device law
  • TÜV Süd Akademie - Management systems for medical device manufacturers
  • TÜV Süd Akademie - Risk management for medical devices according to DIN EN ISO 14971
  • TÜV Süd Akademie - Requirements for suppliers in medical engineering
  • TÜV Süd Akademie - Technical documentation for medical devices
  • Quality Austria - Workshop quality management, medical devices
  • Quality Austria - Workshop product documentation, medical devices
  • Quality Austria - process analysis, medical devices

Education

  • PMU – Paracelsus Medizinische Privatuniversität, Salzburg, doctor's degree in medical sciences
  • FH Oberösterreich, Linz, Medical Device Technology


michael.ring@rnb-consulting.at

DI(FH) Dr. Andreas Böhler, MLBT

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

Andreas Böhler

Open Source Software and programming near the hardware level have always been favourite topics of mine. Building medical devices in either of these areas requires more than in-depth technical knowledge and experience.

While working on a project, I'll be glad to guide you long-term, from the initial idea to the final device to the post market surveillance with my knowledge.

Professional Experience

  • Part-time lecturer Upper Austria University for Applied Sciences - Software Lifecycle Processes / Operating systems & IT Security
  • Development Engineer GE Healthcare, Zipf
  • Freelance Software Engineer medPhoton GmbH, Salzburg
  • Scientific staff & QM-System administrator radART Institute, Paracelsus Medical University, Salzburg
  • Universitá degli studi di Pavia, Pavia, Italy

Qualifications

  • gmds - Certificate Medical Informatics
  • bsi Academy - Lead Auditor EN ISO 13485:2016
  • Linux Professional Institute - LPIC-2
  • Linux Professional Institute - LPIC-1
  • TÜV Austria - Certified Medical Devices Advisor
  • TÜV Austria - Data Security Officer

Education

  • JKU - Johannes-Kepler-Universität, Linz, Law and Economics for Technicians
  • PMU – Paracelsus Medizinische Privatuniversität, Salzburg, doctor's degree in medical sciences
  • FH Oberösterreich, Linz, Medical Device Technology


andreas.boehler@rnb-consulting.at

DI Melanie Baumgartner, BSc

Usability Engineering (EN 62366), Medical IT Networks (IEC 80001-1)

Melanie Baumgartner

The increasing degree of innovation in medical technologies leads to a lot of positive aspects, such as the assistance for healthcare professionals and the improved quality of life for patients. Unfortunately, there are also high risks in the development of innovative medical devices. Therefore, it is my obligation to support companies developing their products.

There are two main professional focuses: Usability Engineering allows to implement optimal “user-product interfaces” and, with the help of IT-Risk Management, risks caused by implementing medical devices into a medical IT-network can be analyzed and controlled accurately.

Professional Experience

  • Part-time lecturer, Upper Austria University of Applied Sciences - Project management & Risk-Analysis

Qualifications

  • SANITAS - Certification “IEC 80001-1: Application of Risk Management for IT-networks incorporating medical devices”
  • Calpana - Certified CRISAM® Consultant
  • Calpana - Certified CRISAM® Trainer
  • AUVA - Certified Laser Protection Officer

Education

  • Upper Austria University of Applied Sciences, Linz - Medical Engineering

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

Dr. Stefan Lahnsteiner

Medical Devices Act, Data Protection Act

Stefan Lahnsteiner

Professional Experience

  • Independent lawyer (Ebensee)
  • Continuous Lecturing Activities (WIFI, Österreichische Gesellschaft für Versicherungsfachwissen…)
  • Articling student at Landl + Edelmann Rechtsanwaltspartnerschaft, Vöcklabruck
  • Internship at the court BG and LG Salzburg
  • Research Associate at the University of Linz, Institut für Multimediale Linzer Rechtsstudien, Abteilung für Multimediales Zivilrecht; Lecturing activities AG und Rep Bürgerliches Recht

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

  • Lawyer's Examination
  • JKU - Johannes Kepler Universität, Linz, Doctor's degree in law
  • PLUS - Paris Lodron Universität, Salzburg, Diploma study in law

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

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

Biocompatibility (EN 10993), Toxicity (EN 10993)

Theodor Langer

Professional Experience

  • Founder of Tikopia Consulting

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

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

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