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Christoph Taegert-Kilger
Efficient and standard-compliant medical device development
Christoph Taegert-Kilger
Efficient and standard-compliant medical device development
30 years of experience in structured development of medical devices. Hands-on with your team.
As experienced project manager, system/software architect and quality manager, I support start-ups and established companies with proven practices of system and software engineering, from idea and prototype to approved medical device. I enable your team to integrate these methods successfully and sustainably into the daily project workflow.
From Challenge to Approval
Compliant realization is not trivial but feasible
From Prototype to Product
A working prototype is just the beginning. A safe product requires the application of systematic engineering practices and documentation. It is often necessary to revise the architecture, incorporating the previous implementation as far as possible.
Investors Need to be Convinced
Investors want good ideas with a clear path to market launch. State-of-the-art project methodology with defined milestones creates trust.
You are Looking for Success in EU, perhaps also in USA
The different regulations enable a uniform development methodology, with moderate differences in the clinical proof of benefit. Early planning is the key to success.
Regulations Require Solid Structures
Regulations are based on proven engineering practices. These must be integrated into day-to-day work so that authorities can confirm compliance with requirements without additional effort.
Regulatory Compliance and Quality Assurance in Medical Device Development
FDA and MDR notified bodies require and verify systematic implementation based on proven system and software engineering practices that are aligned with the product risk.
Each step requires documented planning, structured implementation and quality assurance of the result.
The effectiveness, safety and user-friendliness of each product must be proven through meaningful and comprehensible clinical planning with studies and benefit assessment, verification and validation.
You want to understand what to expect and are looking forward to active support so that your idea becomes a safe and market-approved medical device?
Your Systematic Path to an Approved Medical Device
Your idea
Understand the current status, objectives, boundary conditions,
gaps
Create a shared vision
Create structures, close gaps
Clinical and regulatory planning; development planning
Align current activities to the goal
Establish state-of-the-art system and SW engineering
Structured joint development
Involve competent partners: Regulatory, Cyber Security, Usability
Auditable verification, validation and technical documentation
MDR (EU), FDA
Convince authorities, inspire customers
Convince authorities, inspire customers
My systematic approach ensures efficient and standard-compliant development of your medical device and helps you to become self-reliant for the future.
Offerings
On the way to certification of your company and product, I help you to arrive successfully on the basis of efficient and standard-compliant structures and working methods and with competent partners.
Customized packages
- Free initial consultation and preliminary assessment of the challenges
- Startup structure workshop and resulting recommendations
- Establish, train and support proven practices
- Project Manager, Quality Manager, Regulatory Manager for your team
- Establish QMS
- Individual coaching
Work on individual topics with your team
- Risk analysis
- Product specification
- Regulatory plan
- Clinical plan
- Project structuring
Specific training for your team
- Structured state-of-the-art
- medical device development
- Agile software development for medical devices
- Product risk management, dFMEA
- Structured systems engineering
- Project management for medical device development
- Project risk management for medical devices
Secure your free initial consultation!
Customer voices
With his many years of experience, Chris has significantly improved our development methodology as project manager and quality manager. For the CorLector and UniMap project, he has started to establish an efficient QMS and provided us and our investors with a solid outlook on the further development steps. His current preparation of the FDA pre-submission underlines the value of our collaboration.
Dr. Jörg Ströbel
CEO, Epiqure GmbH
My story
With over three decades of experience in medical technology, I combine sound technical know-how and experience of efficient medical device development with international management expertise.
My professional career
- Master computer science, minor physiology (FAU Erlangen)
- Global Executive MBA (USC & JiaoTong – Los Angeles, Shanghai)
- 4 years China, 1 year UK
- Software and system architect for medical devices – 3Soft, Siemens MED
- Overall software project management High-End CT Somatom Definition
- Quality Manager – Siemens Audiological Technology
- Project manager fast-track MDR-compliant Covid-19 ventilator – Draeger Medical
- Hardware project management for startup – BlueWind Medical Revi
- Staff Project Manager – Plexus Deutschland GmbH
Current - Mar 2025
Project structuring, QMS set-up, training and establishing efficient working modes in line with standards, with the aim of MDR and FDA approval – Startup: EpiQure/CorLector GmbH, Nuremberg
What defines me personally
- Married, four adult children
- Ballroom dancing, tournament level
- Cross-country bike tours