We are a dynamic team of experts for your device approval and quality matters. We have a diverse academic background and many years of practical experience in the life sciences.

MedSysCon GmbH: Reinhard Köhler

Reinhard Köhler

Founder & GM, Consultant

Education
University Braunschweig, Diploma in Computer Science.

Core Competencies

  • Over 20 years of corporate experience in medical product development, culminating in a three-year R&D Director role at Stryker CMF – leading 60 employees distributed around 3 sites in US, Ireland and Germany.
  • Building high-performing teams/performance turnarounds
  • Structuring, staffing, aligning & orchestrating medical device organizations.
  • Medical device development, project management, quality management and regulatory affairs
  • Quality Management (ISO 13485, ISO 14971, ISO 62304, MDR, CRF Part 820)
  • Certified Professional for Medical Software (CPMS)
  • Certificate: Quality Management Systems – TÜV Süd
  • Certificate: Regulatory Requirements for Medical Devices – TU Lübeck

Working Skills

  • Medical Imaging and Navigation Systems
  • Coordination of offshore development partners
  • Development of patient specific implants (class III)
  • Medical device software development according to IEC 62304
  • Computer System Validation (CSV)
  • Software Verification and Validation

Dr. Thomas Wehner

Consultant

Education
PhD in Physics – Cologne University

Core Competencies

  • Medical device software development according to IEC 62304
  • Software Architecture, Verification & Validation
  • Computer System Validation (CSV)
  • Project Management
  • Requirements Engineering

Working Skills

  • Test Lead for FDA cleared ordering and tracking system for class III patient specific implants.
  • Turnkey solution for MES to support design and manufacturing of class III patient-specific implants.
  • Management of introduction of paperless electronic instructions for use system (eIFU).
  • Model-driven implementation of pharmaceutical terminology management system.
  • SCRUM product owner
  • Roll-Out of a Continuous Integration System.
  • Certified Project Manager (DIN 69900)

Techniques

  • Domain Analysis
  • Stakeholder View Modeling
  • Agile Processes
  • Process-Based Project Management
  • Model-Centric Software Development
  • User Story Testing
  • Continuous Delivery

Paul Hiller

Consultant

Education
Diploma in Packaging Technology
M.Sc. Packaging, Design and Marketing

Core Competencies

  • Packaging
  • Design Control
  • Cleaning, Disinfection and Sterilization
  • Biocompatibility & Biological Risk Assessment
  • Process Validations
  • Clearance (CE and FDA)

Working Skills

  • Design Transfer of Patient Specific Implants (class III)
  • Transport Validation
  • Supplier Audits
  • Risk Assessment of Sterile Implants
  • Cleaning Strategy for Implants
  • Process Risk Analyses
  • Transfer of sterile implants to the contract packager
  • Implementation of new manufacturing processes for implants and instruments

Technologien

  • Cleaning Technology
  • Cleanroom Technology
  • Packaging Technology
  • Pressing and Crimping
  • Machining Technology
  • Stereo Lithography
  • Surface Finishing
  • Powder Coating