Me: Hans Köhler, Einzelunternehmer
Leveraging my Medical Technology Experience for Your Innovation
From founder to partner: Practical Expertise to Streamline Your Processes
- Develop with Confidence – Launch with Success
- Pragmatic and Results-Driven
- Focused on Your Success
Creating processes that accelerate innovation and ensure safety
Having successfully built and sold a medical technology spin-off myself, I know exactly what hurdles lie ahead – especially when it comes to QMS, validation, and risk management. This experience is the foundation of my mission as a consultant:
I want to support MedTech companies with pragmatic, field-tested expertise in setting up their processes and systems in a way that innovation and compliance go hand in hand. My goal is to have your back by ensuring that your quality management is solid, your validations are robust, and your risks are manageable.
The phrase “Only what is documented counts (in an audit)!” is more than just a cliché in the medical technology industry – it is a fundamental truth. In a highly regulated environment where patient safety is paramount and every decision must be traceable, your documentation forms the backbone of your conformity, quality, and ultimately your market success. It is the tangible proof of your due diligence, your processes, and the safety of your products to Notified Bodies, authorities, and partners.
Development Processes & Requirements Management
PROVEN procedures save a lot of frustration here, not only during development but also throughout the entire product life cycle thanks to clean traceability.
Risk Management & Analysis
Often unloved, yet it is THE key lever from a regulatory standpoint to adjust the required effort to the actual necessities.
Project Management
The combination of classic and agile project management, with sprints based on clear rules and requirements broken down to the task level, resulted in the BEST feedback from both the teams AND upper management.
Product and Process Development
Proceeding purposefully here requires extensive EXPERIENCE – ideally with an overview across all disciplines.
Data Science
Statistics form the foundation in practically all areas. Being able to present data in an understandable way increases commitment and – in conjunction with risk management – allows for tailored solutions.
Test & Process Validation
Through validation and verification, you provide the necessary proof that you meet the promised requirements. This also includes Test Method Validation (TMV) and Computer System Validation (CSV).
Automation
Automation not only offers the opportunity to produce as rationally as possible, but it is also often the only way to obtain reproducible results. Experience and the right implementation partners can DRASTICALLY reduce costly lessons.