Consulting & Planning

Customized to your organization, we guide through the darkness of regulatory affairs, ensuring that you get the big image about WHAT, HOW and WHEN things need to be done, to place your medical device successful on the market.

Regulatory Affairs

Regulations, standards, technical documentation & more…

Dealing with standards is usually time-consuming, as new revisions are constantly coming into force. This results in a constant stream of new requirements for medical device developers, which can easily be overlooked. Although compliance with standards is not legally binding, it is practically unavoidable in order to fulfill legal requirements.

We will provide you with the structure of the technical file, making sure that you understand exactly which content goes to which place.

The essential starting point will be to integrate the regulatory requirements which arise from regulations and standards into the technical file.

We filter the standards which are important to your medical device and create lists of applicable legal requirements.

This method is a solid basis for an efficient requirements engineering for the medical device to be developed.

Writing the technical documentation is not about writing an rigid article! Moreover it is a lively collection of records which will be created during the life cycle of your device to document what has been done in every stage of development and beyond that.

We give 100%  to develop a safe & efficient device which meets the all legal requirements.


Know WHAT and HOW to develop.

Before starting development, it is best to know what and how to develop your device. Tracking requirements is not only helpful for project management, it is also mandatory by law. The requirements management system should be part of the technical file, it does not only contain information about development activities, it is also closely related to usability and risk management content.

We set up a system for managing your product requirements,  guide you how to categorize them and fill it with life.

Regulatory requirements and medical device-specific standards play a key role, because without their compliance the medical device cannot be approved. These form the basis for development planning and an orderly flow of all tasks to be done. The innovative spirit and flexibility of startups often conflict with regulatory requirements of legislators. For every product feature developed, a corresponding requirement must be defined, verified and validated. Arbitrary changes in the development phase should therefore be avoided.

With a careful requirements engineering we make sure that unnecessary work is reduced to a minimum.

Every requirement must be verified after it has been implemented. This means that test procedures must be defined to check whether the specific product properties have been achieved. The relationships between regulatory-, user-, stakeholder-, system- and component-requirements, as well as their test specifications and test reports, will be collected in a traceability table within the technical file. In contrast to verification, items like user requirements, must be validated by usability tests in order to check whether the usage goals are actually achieved.

We plan your verification & validation activities and make sure they are correctly linked to an easy readable traceability table

Requirements Engineering

Risk Management

Control your risks.

Analysis, evaluation, monitoring and control of risks requires systematic planning if nothing should be forgotten. Manufacturers are obliged to maintain a risk management system as a continuous iterative process throughout the life cycle of a medical device.

We plan your risk management activities which have to be performed during the whole life cycle of your device.

Starting the risk analysis is about identification of safety-related features that may affect safety. These provide a useful basis for further risk management, by means of which hazards, hazardous situations and damages are identified. Risk assessment involves quantitatively estimating a probability of occurrence and extent of damage for each hazard, plotting it in a matrix, and determining whether or not a risk is acceptable.

We moderate the risk analysis and make sure that risks are carefully identified and realistically estimated.

If risks are not acceptable, measures will be defined to control the risks. There is an overlap with requirement engineering, as measures can be considered product requirements. The implementation of a measure as well as the effectiveness of the risk reduction will be verified separately and possible new risks considered.

We take care that measures for risk control are well documented and linked to the requirements management system and the risk management report.

Also we support you in biocompatibility, by preparation of the biological assessment plan and the performance of the toxicological risk assessment based on material data sheets and literature research.

Sustain your quality.

Quality management should primarily serve as a guide for the company and its employees in their daily work. Anyway, medical device manufacturers are obliged to define processes within the company and document them in procedural instructions. Quality policy, role descriptions, activities and their interrelationships will be placed in an QM manual which serves as a entry document for your quality management system, whereas standard operating procedures and work instructions define more detailed activities in your company.

We set up a digital system for quality management and propose the standard operating procedures you need to create an efficient workflow for your employees.

Inconsistant or non-existent procedural instructions reduce efficiency, because employees have to think about the procedures over and over again, or because the work is repeatedly done in different ways. Quality management must also comply with normative and legal requirements. Although the company has a high degree of freedom in creating the procedural instructions, some topics must be addressed in any case.

We will make sure that your quality management system will not be a burden for you, keeping the number of documents as small as possible and as big as necessary.

Quality Management

Usability Engineering

Keep it user-friendly.

Usability engineering in medical device legislation is about reducing risks that may arise from using the device. However, a user friendly device beyond the aspect of risk reduction has never been a disadvantage 🙂

For us usability engineering is more than just reducing risks.

Probably the most important document, the purpose definition will contain information about whether or not it is a medical device, the intended users, the environment and a list of user interface components. Following the definition of user requirements, usage scenarios will be developed which consists of a series of tasks that must be completed by the user in order to achieve the desired goal.

We will set up the intended use document, support you by defining use cases, identifying hazard related usage scenarios and planning the usability evaluation.

During the development phase, formative evaluation will be carried out as early as possible. It serves to identify safety related design weaknesses in preliminary prototypes and to initiate fast corrections. After the product’s development phase, hazard-related scenarios will be evaluated including a prototype and several test subjects to demonstrate that a safe product has been developed.

To ensure you build a safe device, we perform usability tests during and after the development stage to figure out possible risks arising from the usage of your device.

Why not making it in a nice way?

The effective use and the safety of a medical device depend significantly on its labeling. Regulations for labeling extend from the user manual to product labeling and the package of a device. There are also specifications regarding the signal colors and symbols to be chosen for the user interface. Labeling has significant overlaps with risk management and usability. Risk reduction measures are often related to the labeling or the instructions for use, which also needs to be validated by usability tests to ensure safe operation.

We identify all the necessary symbols and inscriptions that you need to apply to the device itself and its package.

Many user manuals for medical devices, are written like pharmaceutical package leaflets – not very user friendly.

We do not only create a conform user manual, we layout it in a nice way.

Labelling & User Manual

Design & Development

We support with innovative design proposals, parametrized and production-ready CAD surfaces including the underlying construction, as well as thermodynamic-, CFD- and magnetic simulations.

Product Design & Mechanical Engineering

Design surfaces meet structural components.

A fundamental step before starting product design will be identifying user requirements, so that it becomes clear what is expected for the final product. For product design, users who have contact with the device, such as patients, doctors or service technicians, are particularly important. Once we have defined what users expect from the device, we will brainstorm various concepts in presenting hand sketches, which provide an initial idea of the design, user elements and functionality. In this process, we emphasize not only to deliver innovative designs, but also to consider the manufacturability and to maximize the usability, which has to be checked later in the course of the usability evaluation anyway.

We provide ideas, hand sketches and 3D models to discuss how concepts could be realized, keeping  feasibility in focus.

After a concept has been chosen we continue with the detailed CAD design of the system’s mechanical components. To avoid subsequent iterations, it is advantageous to already know the inner workings of the medical device, such as printed circuit boards or other electronic components, parts or assemblies. Missing CAD data can be measured and remodeled in the course of reverse engineering. Already during the modeling of the outer skin, the design surfaces, we attach great importance to a parameterized model. In this way, adjustments to the geometry of the finished design, such as in the case of subsequent changes to components, can be carried out with minimal effort.

We deliver fully parameterized, production-ready design surfaces and solid modeling of housing parts.

If reverse engineering is needed, we also do CAD reconstruction based on point clouds generated by 3D scans in NURBS surfaces. Missing CAD data of existing components can be reconstructed by means of measurement and fed into the assembly model.

Simulating heat, flow and electromagnetics.

Computer simulations offer a modern and cost-effective alternative to complex test setups minimizing the number of prototypes required. In the case of structurally relevant components, strength and deformation analyses using the finite element method are useful in the course of mechanical design in order to reduce the effort required for subsequent load tests. For problems concerning the flow of fluids, on the one hand in connection with conduits of complex geometries as e.g. in the human vascular system, on the other hand in devices with angled flow directions as e.g. hydraulic dampers or microfluidic components, the CFD method proves to be useful, because also in this case complex tests with prototypes can be omitted.

We offer FEM simulations for structural components, CFD simulations for fluid flow applications in OpenFoam®

For the analysis of electromagnetic problems we use Finite Element Method Magnetics which provides limited solutions in two-dimensional space, but is sufficient for most applications. Besides magneto- and electrostatic analyses, we solve also thermal problems.

We also perform heat transfer simulations and magnetostatic simulations in FEMM® for cases where magnetic fields are involved.