My offer of specific services
Trainings & Workshops
You want training and education perfectly tailored to your company structure? From the wealth of experience gained through many successful indoor training sessions in an international corporation, you can book your customized training from the following focus areas:
- General medical product development – theory and practice – Medical Device Regulation and relevant standards
- Quality management systems
- Development process – Software Lifecycle, SOPs
- Development methods – especially in regulated environments
- Requirements management – Requirements Engineering and requirement traceability
- Building the medical product file – Documentation
- SW Verification & Validation – Planning and traceability
- Software architecture for safety-critical real-time systems
- Agile SW development for medical products
- „Lean“ development methods
- Simultaneous Engineering
The training package or agreed coaching will be tailored to you individually in terms of time frame, either in block events or weekly units. If you want to promote and develop your employees in these or related topics, please feel free to contact me. Depending on your needs and requirements, I will put together a corresponding individual training package or coaching for you.
The implementation is flexible and can be designed to take place on-site at your location or at a seminar venue, in block sessions or spread over multiple modules, or even in the form of an online training.
Interim Management
Have you experienced a critical situation in a burning project where a key person is unavailable, or do you urgently need competent reinforcement for your organization?
Throughout my professional career, I have successfully held various roles and functions, including development, project management, team leadership, and even managing entire development departments.
I am more than willing to take on these or similar responsibilities on an interim basis within your project or organization.
Conceptualization - Development Consulting
You have a need for development consulting at a true expert level?
The conceptualization of a product and the necessary development project for its realization typically require high levels of technical expertise, development experience, and market knowledge. The goal is to find the optimal balance of features, feasibility, development costs, project duration, and product costs. In the discussion between product management and development, the costs and benefits of individual features and additional functions are weighed to ultimately achieve maximum value and attractiveness for the customer within the planned product development budget. Building on this, the technical concept for implementation is then developed in collaboration with systems engineering and the relevant departments.
Having participated in many conceptualization and product definition processes myself,
I can offer precisely tailored consulting services for this: Whether it’s about the systematic approach, bringing together the necessary stakeholders, or realistically estimating the implementation effort—my cost estimation takes into account not only development work but also activities related to verification, validation, and, if necessary, certification.
Requirements Engineering
You want to take your requirements management to the next level?
Effective requirements management requires a systematic approach. Requirements must be hierarchically organized, their dependencies recognized and depicted. In addition to the more obvious functional requirements, non-functional requirements and those from the surrounding system, including specific risk management measures, must be captured and incorporated. And finally, dependencies must be made visible. This is especially crucial for the verifications and validations derived from the requirements (“traceability”) to provide clear evidence of meeting the requirements.
Throughout my professional career, I have built several systems for capturing and tracking requirements, ranging from simple document-based requirement sets to IT-supported requirements management systems. I have also contributed to creating requirement sets in various roles and successfully passed many audits (including FDA), so I am familiar with the auditors’ points of interest.
Your project or organization can benefit from this knowledge, and I am happy to contribute by reviewing your methodology and the content of your product documentation accordingly.
Development Planning
You need a development plan that builds on a norm-compliant development process?
The development planning is typically based on a development process in which the „generic“ development steps and the corresponding „deliverables“ (work packages) are described. For each process step, the inputs and outputs, as well as the responsibilities and work instructions, and if necessary, KPIs, are defined. The standards that must be met at a minimum are specified in norms (e.g., Software Development Process for Medical Devices IEC 62304). Within this framework, the development plan then schedules the specific project contents, allocates resources, and defines the concrete work results.
In the past, I have worked on or been responsible for the creation of development processes several times. Particularly challenging was the development of an agile software development process that still met the requirements of IEC 62304 for a software development process for medical devices.
If you have not yet introduced a „real“ or complete norm-compliant development process, I can advise and support you in introducing a suitable development process.
I have a good overview of the requirements to be met (especially in software development). In a managerial role, I also had to create and be responsible for concrete development plans.
If you are already in the planning phase and don’t have time to introduce a development process before the project starts, it is possible to incorporate the essential elements required by the standards into the development plan; I can also assist you with that.
Systemarchitecture and Systemdesign
If you haven’t implemented Systems Engineering yet, you should talk to me!
Because creating a system architecture is a crucial lever for increasing efficiency in development and improving the quality of your development results. Through a cross-system representation of functions and processes, collaboration and mutual understanding across all disciplines are synchronized, allowing for targeted work on implementation and system integration.
Introducing Systems Engineering was a particular concern of mine as a development manager. There was extreme „silo thinking“ in development; you know how it goes: the exchange between specialist groups is poor, and requirements are shuffled back and forth between them (e.g., implementing a function in hardware or software). The system architecture and system design bring clarity here because they clearly and precisely define and address how and with what the requirements are to be realized in the system.
I offer all this knowledge and experience to actively support you in introducing Systems Engineering or in creating and representing a system design.
Development Services
Do you need an experienced embedded developer for your project?
At the core of my heart, I am a passionate developer.
I have years of experience in software development, particularly in low-level programming, understand the challenges of real-time systems, and have designed and developed a real-time bus system in an international corporation.
Verification and Validation
Do you want to transition from simple „testing“ to a medical device-compliant verification and validation process?
The difference between testing and verification & validation can be seen in the systematic approach: While testing simply involves more or less intuitively trying to find errors and verify the function, verification strives to ensure faultlessness and exact compliance with the specified functions based on the underlying specifications. Embedded in the development process, verification & validation demands cascaded methods: Verification begins already in the implementation phase with code reviews, testing of functions and function groups, and progresses through integration tests to the final system verification. A diverse repertoire of testing methods is used to eliminate hidden errors that could not be found in the final system under normal conditions. Finally, the final validation ensures that the software meets the needs and expectations of users in the real application environment.
In my role as SW Development Manager, I advocated for establishing a separate verification group within the company, independent of development. This ensured independent quality assurance while allowing verification activities to start simultaneously with development. Employees were involved as early as the requirements and testing phase. Verification engineers provide valuable inputs regarding acceptance criteria, testability, and the necessary infrastructure.
Your development process will benefit from this approach.
Documentation and Approval
You see your technical documentation critically but aim to succeed confidently in the upcoming approval process?
The basis for a successful approval always lies in a comprehensive and high-quality development record. Particularly, the results described under the activity descriptions: Development Plan, Requirements Management, Risk Management, and Verification & Validation must be well-documented and complete. Specifically, the correlation between requirements and verification and validation must be clearly depicted and traceable.
With the experience gained from numerous successful product audits and approvals at an international medical device manufacturer in a responsible position, I am familiar with the pitfalls in document preparation and the weaknesses typically uncovered by auditors. I can assist you in addressing these issues in advance.
Re-Engineering
You have a great product that you can no longer produce because components are no longer available, and it is no longer up to date with current technology, but you would like to keep it in your portfolio?
When a successful product becomes outdated, a re-engineering project is often necessary. This could be due to electronic components no longer being available, technical solutions or interfaces becoming obsolete (e.g., serial interface), or modern features being impossible to implement (e.g., app control). Often, the development record is also outdated as the legal and regulatory landscape has changed dramatically over time.
Approaching re-engineering with naivety can lead to surprises because the effort and necessary expertise are often underestimated. A re-engineering project should start with the same steps as a new product, including re-conceptualization, product definition, and requirement capture. It’s important to realize that simply swapping out electronics and/or software will not be sufficient for a successful relaunch. Instead, it requires a complete development process in line with current technological standards.
I find re-engineering projects particularly challenging because the goal is to make an already proven and good product even better.
For your re-engineering project, I can offer all the services mentioned above and additionally assist in planning the new electronics and software system. I also have expertise in code porting – often, it’s more efficient (and safer) to integrate an existing, good algorithm into a new system.
Reverse Engineering
You have a great product that nobody knows anymore how it works, and it comes from a time when documentation was not part of the development process, but you would like to keep it in your portfolio?
Reverse engineering becomes necessary when, for example, re-engineering is required but development documents and crucial design information are missing. Another scenario is when updating a product, due to today’s stricter requirements for documentation, corresponding documents need to be (re)created. Reverse engineering may also be necessary to preserve valuable technical knowledge.
I entered the embedded development field almost 30 years ago, so I am familiar with the systems from nearly the beginning of the era. Personally, I enjoy analyzing and understanding older, interesting designs.
If you have a need for reverse engineering services, I would be particularly delighted to take on the task!