Consulting for compliant development and approval of medical devices (MDR, FDA)
Christoph Taegert-Kilger Medizintechnikberatung
DarmstadtNew on Amplifa
About CTKmedical
CTKmedical is the medical technology consultancy of Christoph Taegert-Kilger, located in Darmstadt. The offering targets startups and established companies in Medtech and Life Sciences, supporting projects from the initial idea through the prototype to the approved medical device. The consulting includes system and software engineering, product risk management (dFMEA), regulatory and clinical planning, as well as verification, validation, and technical documentation according to MDR (EU) and FDA. Additionally, QMS establishment, interim roles as project manager, quality manager, or regulatory manager, workshops, training, and individual coaching are offered. With approximately 30 years of experience in structured medical device development, emphasis is placed on the practical integration of methods into daily project workflow. The consulting service is a service; no own manufacturing takes place.
- Site
- Darmstadt
- Processes
- Consulting for compliant medical device development (MDR, FDA), Project Management / Interim Quality Manager / Regulatory Manager, QMS Establishment, System and Software Engineering, Risk Analysis / Product Risk Management (dFMEA), Regulatory and Clinical Plan, Verification, Validation, Technical Documentation, FDA pre-submission preparation
- Materials
- System and Software Engineering, Product Risk Management / dFMEA, Regulatory and Clinical Planning, QMS Establishment, Verification and Validation, Workshops and Trainings
- Industries
- Medical Technology (Medtech), Life Sciences, Diagnostics
- 01
Initial consultation and mini-workshop
- 02
Current state analysis and goal definition
- 03
Clinical and regulatory planning
- 04
System and software engineering
- 05
Risk analysis (dFMEA)
- 06
Verification and validation
- 07
Technical documentation
- 08
MDR (EU) / FDA approval
Services and Methods
System and Software Engineering
State-of-the-art methods for structured medical device development.
Product Risk Management / dFMEA
Risk analysis based on proven, product-specific practices.
Regulatory and Clinical Planning
Regulatory plan, clinical plan, and benefit assessment for MDR and FDA.
QMS Establishment
Establishment of compliant structures and procedures until certification.
Verification and Validation
Auditable evidence and technical documentation for Notified Bodies and FDA.
Workshops and Trainings
Topics such as agile software development, systems engineering, and project management in medical technology.
Site
Darmstadt
DEBusiness address
Service Areas
Inside the production
Industries
Additional services
Reference customers