<p>Two-year part-time, specialized Master of Business Administration (MBA) in the German "Medical Valley" Tuttlingen, with the following topics:</p>
<ul>
<li>Economics</li>
<li>Finance</li>
<li>Accounting</li>
<li>(International) Marketing Management</li>
<li>Management Information Systems</li>
<li>Project Management</li>
<ul>
<li>Simulation of case study</li>
</ul>
<li>Production Management</li>
<li>Strategic Management</li>
<li>Corporate Leadership</li>
<li>Intercultural Management
<li>Business Law</li>
<li>Quantitative Methods (Statistics)</li>
<li>Business plan</li>
<ul>
<li>3-day business planing in groups and final pitch</li>
</ul>
</ul>
Master thesis: <p><b>Strategic Alliance of Diagnostic Imaging and Prosthesis Industry for Orthopedic Surgery</b></p>
Certified Professional for Medical Software
Medical Device
2021/09
Two-day seminar by M. Hölzer-Klüpfel and S. Wittorf, covering the following topics:
<ul>
<li>Medical Device Regulation (EU) 2017/745</li>
<li>Quality Management</li>
<li>Risk Management</li>
<li>Software Lifecycle Management</li>
<li>Usability (Human Factors Engineering)</li>
<li>Document Management</li>
<li>Medical Informatics</li>
<li>IT Security for Medical Devices</li>
</ul>
Final exam
SQL NanoDegree
Database
2021/05
Assignments of Real-World Projects that were reviewed by experts in the following topics:
<ul>
<li>DBMS (Relational and Non-Relational)</li>
<li>Normalizing Data</li>
<li>Data Definition Language (DDL)</li>
<li>Data Manipulation Language (DDL)</li>
<li>Consistency with Constraints</li>
<li>Performance Tuning with Indexes</li>
<li>SQL Subqueries</li>
<li>Temp Tables</li>
<li>SQL Window Functions</li>
<li>SQL Advanced Joins</li>
<li>Deforestation Exploration</li>
<li>Udiddit Social News Aggregator</li>
</ul>
Programming for Data Science with Python NanoDegree
Data Science
2020/10
Assignments of Real-World Projects that were reviewed by experts in the following topics:
<ul>
<li>SQL</li>
<li>Python Data Types and Structures</li>
<li>Python Control Flow and Functions</li>
<li>Scripting</li>
<li>NumPy</li>
<li>Pandas</li>
<li>Git</li>
</ul>
Certified Financial Modeler
Finance
2023/05
4 comprehensive, Excel-based models reviewed by Prof. Dr. Häcker and Prof. Dr. Ernst:
<ul>
<li>Company Valuation</li>
<li>Corporate Finance</li>
<li>Leveraged Buyout</li>
<li>Portfolio Management</li>
</ul>
Ph.D in Physics
Physics
1994/12
Accelerator-Based, Experimental Nuclear Physics and Detecting Gamma Rays with Multi-Detector Arrays
<ul>
<li>Investigation of gamma rays to determine the lifetime of excited nuclei using the Doppler effect</li>
<li>Preparation of experimental setup with plunger device</li>
<li>Planning, implementing and conducting experiments at Van de Graaff accelerator lab in Roskilde, Denmark</li>
<li>Analysis of acquired data and publications in peer-reviewed journals</li>
</ul>
Certified C# Software Engineer
C#/.NET
2021/11
24 topic-related assignments that were reviewed by the C# teacher in the following areas:
<ul>
<li>Program structure</li>
<li>Variables</li>
<li>Constants</li>
<li>Data types and operators</li>
<li>Input and output</li>
<li>Logical operators and comparison operators</li>
<li>Control structures and loops</li>
<li>Methods</li>
<li>Object-oriented programming</li>
<li>Exception handling</li>
<li>Graphics programming</li>
<li>Working with XML files</li>
<li>WPF</li>
<li>Snake and memory games</li>
<li>Web browser with C#</li>
<li>Database programming and queries</li>
<li>UWP</li>
</ul>
Certified Database Developer for Microsoft SQL Server
Database
2019/05
15 topic-related assignments reviewed by the database teacher, and final exam in the following areas:
<ul>
<li>MS Windows Server installed on VMWare</li>
<li>MS SQL Server installation</li>
<li>Development of relational database</li>
<li>Development of frontend and backend services</li>
<li>Generation of reports</li>
<li>Server-side programming with triggers</li>
<li>Procedures and functions</li>
<li>Administration of SQL Server</li>
</ul>
Certified Financial Engineer
Finance
2017/02
Assignments, final exam and thesis at Deutsche Börse, with the following topics
<ul>
<li>Pricing of options and futures</li>
<li>Binomial model</li>
<li>Black-Scholes and Black-Scholes-Merton model</li>
<li>Greeks</li>
<li>Basic strategies bullish and bearish</li>
<li>Neutral option strategies</li>
<li>Situational application of various strategies</li>
<li>CAPM</li>
</ul>
Final thesis with the title: "Valuation of Staged Medical-Device Projects and Critical Review of Realistic Cases"
Professional Scrum Master I
Scrum (Agile)
2024/02
PSM I is recognized by the industry as a certification that demonstrates a fundamental level of Scrum mastery. As a PSM I certification holder one has given proof that Scrum was understood as described in the Scrum Guide and how to apply Scrum as a Scrum Master in Scrum Teams.
<p>Final exam<p>
Professional Scrum Product Owner I
Scrum (Agile)
2024/02
PSM I is recognized by the industry as a certification that demonstrates a fundamental level of Scrum mastery. As a PSM I certification holder one has given proof that Scrum was understood as described in the Scrum Guide and how to apply Scrum as the Product Owner in Scrum Teams.
<p>Final exam<p>
International Scrum Master Foundation (Scrum Guideline 2020)
Scrum (Agile)
2021/05
Introductory self-study course into the Scrum Guideline, with final exam
Cybersecurity for Medical Devices
Cyber Security
2024/04
Presentations by industry experts:
<ol>
<li>Dipl.-Ing. Hans Wenner (VDE):</li>
<ul>
<li>5G networks in clinical environment</li>
<li>Regulatory approach for medical devices and non-medical devices in 5G network</li>
</ul>
<li>Dipl.-Ing. Jan Küfner (TÜV Süd):</li>
<ul>
<li>Cybersecurity from the viewpoint of the Notified Body</li>
<li>Penetration testing</li>
</ul>
<li>Dipl.-Inform. Sebastian Schreiber (CEO SySS):</li>
<ul>
<li>Penetration testing</li>
<li>Live hacking demo into vulnerable systems/devices</li>
</ul>
<li>Dipl.-Wi.-Ing. Martin Schneider (CIO University Clinic Erlangen):</li>
<ul>
<li>Information security in Clinics</li>
<li>Statutory and normative requirements</li>
</ul>
<li>Dr.-Ing. Georg Heidenreich (Siemens Healthineers):</li>
<ul>
<li>IEC 81001-5-1:2021</li>
<li>Next steps in cybersecurity norms and standards</li>
</ul>
</ol>
Certified in Cybersecurity
Cyber Security
2024/12
Foundational cybersecurity by one of the most renowned training and certification providers in the cybersecurity space:
<ol>
<li> Security Principles</li>
<li>Disaster management:
<ul>
<li>Business Continuity (BC)</li>
<li>Disaster Recovery (DR)</li>
<li>Incident Response Concepts</li>
</ul>
</li>
<li>Access Controls Concepts</li>
<li>Network Security</li>
<li>Security Operations</li>
</ol>
Risk Management for Cybersecurity acc. to the MDR
Medical device
2021/10
<ul>
<li>Norms, standards and guidance</li>
<ul>
<li>IEC TR 60601-4-5:2021</li>
<li>IEC 81001-5-1:2020</li>
<li>ISO 27005:2018</li>
<li>IEC 62304 and IEC 82304-1</li>
<li>BSI 200-3</li>
<li>AAMI TIR 57:2016</li>
<li>ISO/TR 24971:2020</li>
<li>FDA Cybersecurity Guidance</li>
</ul>
<li>Threat modelling (STRIDE) with practical exercises</li>
<li>Cryptography</li>
<li>CIA Triade</li>
<li>Vulnerabilities from CVE and CVSS</li>
<li>Risk management plan</li>
<li>Risk evaluation</li>
<li>Risk report</li>
<li>Change management</li>
<li>Security by Design</li>
<li>Security during the whole lifecycle</li>
</ul>
MDR-Expert - TÜV
Medical Device
2023/12
<p>Collection of 5 seminars by TÜV Süd Academy, with final exam:</p>
<ul>
<li>Medical Device Regulation (MDR) in Detail</li>
<li>Quality Management System implementation acc. to MDR</li>
<li>Post-Market Surveillance and Post-Market Clinical-Follow-Up</li>
<li>Unique Device Identification</li>
<li>Person Responsible for Regulatory Compliance</li>
</ul>
Quality Management System implementation acc. to Medical Device Regulation
Medical Device
2023/11
Seminar how to implement the ISO 13485 norm into the QMS system, in conformity with the Medical Device Regulation:
<ul>
<li>ISO 13485:2016</li>
<li>Economic operators acc. to MDR</li>
<li>Requirements for labelling, IFU</li>
<li>Requirements for PMS</li>
<li>Requirements for PMCF</li>
<li>Conformity of marketing material</li>
<li>Liability</li>
<li>Unique Device Identification</li>
</ul>
Unique Device Identification (UDI) im Detail
Medical Device
2023/11
<ul>
<li>What is the UDI</li>
<li>IMDRF guidance</li>
<li>FDA Final Rule</li>
<li>UDI definition in the EU</li>
<li>How the UDI is coded</li>
<ul>
<li>Basic UDI-DI</li>
<li>UDI-DI</li>
<li>UDI-PI</li>
</ul>
<li>Quality management of UDI</li>
<li>Packaging levels</li>
<li>Quality assurance of UDI</li>
<li>UDI databases</li>
</ul>
Person Responsible for Regulatory Compliance
Medical Device
2023/11
Seminar for PRRC position and final exam:
<ul>
<li>Legal framework according to MDR Article 15</li>
<li>Responsibilities, sharing & delegation among several persons</li>
<li>Job description</li>
<li>Conformity of devices produced under QMS</li>
<li>Technical documentation and Declaration of Conformity</li>
<li>Post-market surveillance system</li>
<li>Reporting of serious incidents, FSCA and FSN</li>
<li>Issuing the statement for investigational devices</li>
<li>Definition of trends and reporting of trends</li>
<li>Provisions on fines according to German law (MPDG) </li>
<li>Guidance by MDCG 2019-7, MDCG 2021-25</li>
</ul>
Risikomanagement für Medizinprodukte-Software nach ISO 14971
Medical Device
2022/07
<ul>
<li>Foundations of risk management</li>
<li>Risk management process acc. to ISO 14971</li>
<li>Differences between ISO 14971:2019 and ISO 14971:2012</li>
<li>EU harmonization of ISO 14971:2019</li>
<li>Risk management analysis</li>
<li>Hazards and hazardous situations</li>
<li>Risk management documentation</li>
<li>Risk management evaluation</li>
<li>Risk matrix with likelihood of occurrence and severity of risk</li>
<li>Risk management planning</li>
<li>Root cause analysis</li>
<li>Failure Mode Effects Analysis, Fault Tree Analysis</li>
<li>Preliminary Hazard Analysis</li>
<li>Typical software fault patterns</li>
<li>IT security</li>
<li>Guidance from TIR24971-2020</li>
<li>Guidance from IEC/TR 80002-1</li>
<li>Risk management reporting</li>
</ul>
Vigilanz für Medizinprodukte
Medical Device
2021/01
<ul>
<li>Vigilance</li>
<li>Vigilance and its interaction with PMS and Clinical Evaluation</li>
<li>Serious and non-serious incidents</li>
<li>Medical Device Incident Reporting</li>
<li>BfArM's and FDA role</li>
<li>Interaction with local authorities</li>
<li>Establishing processes for vigilance</li>
</ul>
Post-Market Surveillance and Post-Market Clinical Follow-Up of Medical Devices
Medical Device
2020/02
<ul>
<li>Requirements of PMS/PMCF acc. to the MDR</li>
<li>PMS/PMCF throughout the lifecycle of a medical device</li>
<li>Trend reporting in PMS</li>
<li>How to monitor undesirable side effects and match them with the Risk Management File</li>
<li>How to monitor misuse of device</li>
<li>Vigilance as part of PMS</li>
<li>Approval of PMCF studies</li>
<li>Market surveillance</li>
</ul>
Training for background, tasks and responsibilities of PRRC:
<ul>
<li>Legal framework according to MDR Article 15</li>
<li>Responsibilities, job description and assignment</li>
<li>Conformity of devices produced under QMS</li>
<li>Technical documentation and DoC</li>
<li>PMS</li>
<li>Reporting of serious incidents, FSCA and FSN</li>
<li>Issuing the statement for investigational devices</li>
<li>Definition of trends and reporting of trends</li>
<li>Sharing and delegation among several persons</li>
<li>Guidance by MDCG 2019-7, MDCG 2021-25</li>
</ul>
Training on draft Medical Device Regulation (Aug 2016) and MEDDEV 2.7.1 Rev. 4
Medical Device
2017/01
Targeted training by Dr. Bassil Akra, TÜV Süd for class III implantable devices:
<ul>
<li>General overview of the MDR</li>
<li>New experience on MEDDEV 2.7.1 Rev. 4</li>
<li>New clinical and post-market requirements</li>
<li>Clinical workshop</li>
</ul>
Workshop on Prosthetic Joint Infection (PJI)
Medical Device
2016/10
<ul>
<li>Theory</li>
<li>Diagnosis and definition of PJI</li>
<li>Histopathological diagnosis of infections </li>
<li>Standard diagnostic algorithm</li>
<li>New methods for biofilm-detection</li>
<li>Surgical approaches: State of the art</li>
<li>Case studies</li>
<li>Systemic antimicrobial treatment: State of the art</li>
<li>Exercises in simulated OR with antibiotic-loaded cement</li>
<li>Demonstration of sonication & biofilm detection methods</li>
<ul>
Zertifizierter Börsenhändler EUREX
Finance
2015/05
<ul>
<li>Stock exchange rules</li>
<li>Trading conditions</li>
<li>How trading on the EUREX works</li>
<li>Procedure of trading on EUREX</li>
<li>Orders on the EUREX</li>
<li>Protection mechanisms, market orders</li>
<li>Price formation on the EUREX</li>
</ul>
C# .NET - Creating Object-Oriented Solutions Using C#
C#/.NET
2022/06
<ul>
<li>Classes and objects</li>
<li>Data encapsulation and access modifiers</li>
<li>Constructors and destructors</li>
<li>Inheritance in C#</li>
<li>Abstract classes and interfaces</li>
<li>Polymorphism and overloading</li>
<li>Method overloading and overriding</li>
<li>Operator overloading</li>
<li>Advanced OOP concepts in C#</li>
<li>Delegates and events</li>
<li>Generics and their restrictions</li>
<li>Extension Methods</li>
<li>Error handling and exception handling</li>
<li>Creating your own exception classes</li>
<li>Working with collections</li>
<li>IEnumerable</li>
<li>Arrays lists and dictionaries</li>
<li>Using LINQ for complex data queries</li>
<li>Iterators and the foreach loop</li>
<li>Design patterns in C#</li>
<li>Application examples in C#</li>
<li>Basics of unit testing</li>
<li>Testing with MSTest or NUnit</li>
<li>Mocking and dependency injection</li>
<li>Memory management</li>
<li>Using blocks</li>
</ul>
Enterprise Development Platform (EDP) Fundamentals Training
Software Dev Platforms
2023/02
Corporate development platform for software application:
<ul>
<li>Deployment pipelines</li>
<li>Static code analysis</li>
<li>Dockerfiles </li>
<li>YAML</li>
<li>Kubernetes</li>
<li>Microservices</li>
<li>Lots of practical exercises</li>
</ul>
Microsoft-Certified Azure Fundamentals
Cloud
2020/11
Essential services and final exam:
<ol>
<li>Cloud computing:</li>
<ul>
<li>Cloud models public, private, and hybrid</li>
<li>Shared responsibility model</li>
<li>Consumption-based model</li>
<li>Cloud pricing models</li>
</ul>
<li>Benefits of cloud computing:</li>
<ul>
<li>Availability and scalability</li>
<li>Reliability and predictability</li>
<li>Security and governance</li>
</ul>
<li>Cloud service types:</li>
<ul>
<li>IaaS</li>
<li>PaaS</li>
<li>SaaS</li>
</ul>
<li>Core architectural components:</li>
<ul>
<li>Azure regions, region pairs, and sovereign regions</li>
<li>Availability Zones</li>
<li>Resource and management groups</li>
</ul>
<li>Azure compute and networking services:</li>
<ul>
<li>Container instances, VMs, and functions</li>
<li>Azure Web Apps, containers, and VMs</li>
<li>Azure Virtual Networks, Azure virtual subnets</li>
<li>Azure DNS, VPN Gateway</li>
<li>Public and private endpoints</li>
</ul>
<li>Azure storage services:</li>
<ul>
<li>Storage tiers</li>
<li>Redundancy options</li>
<li>Storage types and accounts</li>
<li>Migration options</li>
<li>Public and private endpoints</li>
</ul>
<li>Azure identity, access, and security:</li>
<ul>
<li>SSO Authentication</li>
<li>RBAC</li>
<li>Defense in Depth</li>
<li>Defender for Cloud</li>
</ul>
</ol>
Strahlenschutz-Spezialkurs CT
Medical Device
2014/05
<ul>
<li>Indication for CT examinations</li>
<li>Device and detector technology</li>
<li>Quality assurance and quality control</li>
<li>Dose measurement parameters - Patient exposure</li>
<li>Scan parameters: Importance for image quality and dose</li>
<li>Instrumental factors influencing the dose</li>
<li>User-related factors influencing the dose</li>
<li>Radiation exposure of the patient</li>
<li>Methods for estimating patient exposure</li>
<li>Measures to reduce the patient's dose - Radiation protection equipment, patient positioning</li>
<li>Special techniques (e.g. cardio-CT, CT fluoroscopy, etc.) </li>
<li>Practical exercises and case studies on dose-reducing measures and selection of examination technique</li>
</ul>
Statistical Design and Analysis of Clinical Studies for Medical Devices I
Statistics
2020/12
Small-group hands-on biostatistics training by Dr. Thomas Keller from Acomed:
<ul>
<li>Data scaling</li>
<li>Data structure</li>
<li>Data setup</li>
<li>Continuously scaled data</li>
<li>Distributions</li>
<li>Testing with Confidence Intervals</li>
<li>Testing of superiority and non-superiority</li>
<li>Hypothesis testing</li>
</lu>
ISO 14155 Basic Training
Medical Device
2018/10
<ul>
<li>Basics of clinical research</li>
<li>Basics of biometrics</li>
<li>Declaration of Helsinki</li>
<li>ICH/GCP</li>
<li>Laws/guidelines</li>
<li>Safety aspects of a clinical trial</li>
<li>Practical aspects</li>
<li>Audits/Inspections</li>
<li>Discussion, performance review, training evaluation</li>
</ul>
Klinische Studien für Medizinprodukte
Medical Device
2012/11
<ul>
<li>Definition of terms</li>
<li>Regulatory requirements</li>
<li>Ethical aspects</li>
<li>Clinical trial preparation</li>
<li>Clinical trial financing</li>
<li>Biometrics</li>
<li>Data management</li>
<li>Insurance in case of damage to persons involved</li>
<li>Quality assurance</li>
<li>Clinical trial reporting</li>
<li>Clinical trial safety</li>
<li>Clinical trial publication</li>
</ul>
FAA Single-Engine Pilot Licence
Aviation
1996/07
Daily flight training program over 4 weeks to acquire the single-engine FAA certificate:
<ul>
<li>Theory lessons in the morning at Puyallup (Pierce County Airport)</li>
<li>40 training flights at Puyallup (Pierce County Airport) in State of Washington, US</li>
<li>2 long-distance, cross-country solo flights in States of Washington and Oregon, US</li>
<li>Final theory and flight exam at Renton Municipal Airport in July 25, 1996</li>
</ul>
Statistical Design and Analysis of Clinical Studies for Medical Devices II
Statistics
2020/12
Small-group hands-on biostatistics training by Dr. Thomas Keller from Acomed:
<ul>
<li>Statistical hypothesis testing</li>
<ul>
<li>parametric and continuously scaled data</li>
<li>t-test, ANOVA, Mann-Whitney-U test, Wilcoxon test</li>
</ul>
<li>Objectives and endpoints in medical device studies </li>
<li>Data setup</li>
<li>Sample size calculation</li>
<li>Linear and logistic regression</li>
<li>Survival analysis</li>
<li>Testing with Confidence Intervals</li>
<li>Testing of superiority and non-superiority</li>
<li>Hypothesis testing</li>
</ul>
Private Pilot Licence for Gliding
Aviation
1982/01
Glider (soaring) training between April 28, 1979 - November 14, 1981 at Lemwerder Airfield, Germany:
<ul>
<li>Total of 264 flights for achieving the pilot license</li>
<li>Cross country flights:</li>
<ul>
<li>Uelzen - Wilsche, 51 km on July 20, 1981</li>
</ul>
</ul>
Systems Security Certified Practitioner (SSCP)
Cyber Security
2024/07
<p>- Security Operations and Administration</p>
<p>- Access Controls</p>
<p>- Risk Identification, Monitoring, and Analysis</p>
<p>- Incident Response and Recovery</p>
<p>- Cryptography</p>
<p>- Network and Communications Security</p>
<p>- Systems and Application Security</p>
Cybersecurity - IT-Security for Medical Devices
Cyber Security
2024/09
<p>Terms and regulatory requirements in the area of cybersecurity: MDR, FDA</p>
<p>Establishing a secure life cycle</p>
<p>Carry out threat modeling</p>
<p>Assessing security risks</p>
<p>Basics of secure design and secure development of secure software</p>
<p>Normative requirements and sources:</p>
<ul>
<li>MDCG 2019-16</li>
<li>IEC 81001-5-1</li>
<li>IEC TR 60601-4-5</li>
<li>FDA QMS Guidance 2023</li>
<li>FDA Postmarket Guidance</li>
</ul>
<p>Practical tools:</p>
<ul>
<li>STRIDE</li>
<li>CVE-DBs</li>
<li>OWASP</li>
</ul>
<p>Exercises</p>
Security Analyst NanoDegree
Cyber Security
2025/12
<p>Four technically demanding projects that were reviewed:</p>
<ol>
<li>Fundamentals of Defending Systems</li>
<li>Analyzing Security Threats</li>
<li>Assessing Vulnerabilities and Risk Mitigation</li>
<li>Monitoring, Logging and Incident Response</li>
</ol>