MEET OUR TEAM

We are a diverse and international team but with the same passion.

Matthias Größler

MANAGING DIRECTOR & PRODUCT SAFETY EXPERT

• Functional Safety acc. to ISO 26262 & IEC 61508

• Safety of the intended Functionality (SOTIF) acc. to ISO/PAS 21448

• Automotive SPICE® Provisional Assessor

Christoph Hauck

Managing director & Senior QM and Safety Expert
• Strategical consulting

• Functional Safety acc. to ISO 26262 & IEC 61508

• Automotive SPICE® Provisional Assessor

Wolfgang Mickisch

Associate & functional safety expert

• Strategical consulting

• Responsible for expert partner network

• Customer relation management

Dr. Filipa Campos-Viola

Medical Device Expert
• Risk Management (ISO 14971), Regulatory Affairs

• Systems Engineering, Project Management

Julian Pelz

Automotive Product Safety Consultant
• Functional Safety acc. to ISO 26262

• Automotive SPICE® Provisional Assessor

Paolo Massari

Medical Device Expert
• Internal Auditor ISO 9001:2015

• Lifecycle of AIMDs, clinical and post-market experience

• Safety evaluation, Verification and Validation, Usability

Stephen Cobeldick 

Senior Consultant Automotive Functional Safety
• ISO 26262 certified Safety Specialist

• Deductive and Inductive Safety Analyses

• System and HW Safety Concepts

Sarah Condon 

Medical Device Consultant

• Lead Auditor ISO 13485:2016

• Quality Management, MDSAP

• 510k submissions (FDA)

Zhencan Xu

junior Medical Device consultant
• Product Lifecycle Management

• Regulatory Affairs: Certification in China

MEET US AT EVENTS

You can find out what events we joined in the past and what we performed at the events.

Functional Safety meets ADAS

Vöhlinschloss, Nov. 18, 19 – 22, 2019

  • Functional Safety meets ADAS is a innovative ISO 20202 training organized by FSQ Experts GmbH.

  • Demands on experience in functional safety (ISO 26262) engineering for Advanced Driver Assistance Systems (ADAS) and automated driving (AD) grows. This training aims to prepare the developers and companies for this challenge.

see the introduction >

MedTecLIVE

Nürnberg (online), Jun. 30 – Jul. 2, 2020

  • MedtecLIVE is one of the biggest international events for the production of medical technology in Germany.

  • In 2020 we attended MedTechLIVE as an exhibitor and held a pitch about our contribution supporting start-ups entering the medical device market.

see the pitch >

*Please note the MDSAP guidance document referred to in this video is now outdated, the new guidance can be found at https://www.fda.gov/media/87544/download

Kompetenzpool Zulassung:

online XING event, Jul. 30, 2020

  • Kompetenzpool is a a cycle of talks about medical technology organised by the Medical Valley. Medical Device professionals come together to share their knowledge about ongoing topics in medical technology.

  • In a recent event, we had the opportunity to present in collaboration with Matthias Hölzer-Klüpfel our common experience with Medical SPICE (a process assessment model defined in the  Guideline VDI 5702 Part 1).

see the introduction at Medical Valley >

12. Innovation Forum Medizintechnik 

Tuttlingen/online, Oct. 14, 2020


  • Innovation Forum is a platform for the presentation of innovative ideas,  technologies and products in medical technology.

  • We presented “Future: Data-driven post-market surveillance for every medical device!”. Click here to read the full abstract.

MedConf 2020

Munich/online, Oct. 20 – 22, 2020 


  • MedConf is a big conference in Munich around the topics of software development and device development in medical technology.

  • We presented “(teil-)Automatisierte Medizingeräte: Wie kann SOTIF die Sicherheit des Patienten verbessern?“, together with our partner Olivier Bockenbach

safetronic. 2020 

Stuttgart-Fellbach/online, Nov. 9 – 11, 2020 


  • safetronic provides a practical update on the trends of functional safety in the automobile industry, such as ISO 26262, SOTIF as well as autonomous driving and artificial intelligence.

  • We joined the meeting as an exhibitor

MedTecLIVE 2021

online, Apr. 20 – 22, 2021  

 

  • MedtecLIVE is one of the biggest international events for the production of medical technology in Germany.

  • We are sponsor of the Young Talent Award and our colleague Dr. Filipa Campos-Viola was jury of the award.

  • In the session of international market, we gave a talk about market entry in China with focus on regulatory requirements from NMPA.

  • We presented about proactive Post-market Surveillance, which is required by MDR, and our approach of an proactive system.

safe.tech 2021 

online, Apr. 20 – 22, 2021 

  • safe.tech is an experts meeting organised by TÜV Süd for the topic functional safety.

  • We presented our agile development model EchoScrum® in the community and received many interests.

Automotive SYS

online, May 10 – 12, 2021  

  • This conference organised by VDA is accepted by the international assessor certification scheme (intacs™) as active or passive experience evidence (EE-EP, EE-AC) for certification as SPICE Competent or Principal Assessor.

RAPS Convergence 2021 

online, May 10 – 12, 2021 


  • RAPS Euro Convergence is an event for regulatory professionals operating in Europe and other countries who want to comply with European regulatory policies.

  • We presented about Post-market Surveillance

UPCOMING EVENTS

Maybe you have also attended the events above and got to know us. Maybe we have never met yet.

In any case, you can still meet us in person in the following events!

Refurbishing Medical Devices: The Update Journey

online Webinar, May 25 2021

  • In this webinar, Critical Software will focus on medical devices updates and how to avoid some key issues including: Regulations relevant to the refurbishment process and the impact of medical device updates on certification; How to use legacy code in a refurbishment project and the risks and limitations you should account for; How to guarantee that updates on UxD won’t jeopardise patients’ safety and certification.

  • Our colleague will present the section from the regulatory perspective.

Functional Safety meets ADAS

online E-learning, autumn 2021

  • Functional Safety meets ADAS is a 4-days ISO 262626 workshop training and consulting event organized by Hochschule Kempten and Wolfgang Michisch, the co-founder and managing director of FSQ Experts.

  • Also this year, participants have a chance to enrich their knowledge in functional safety (ISO 26262) engineering for ADAS and AD.