Made in Germany

For safe medical devices

Methodology

Delivered? Promised.

Medical engineering means looking ahead even further. Here at Mechatronic, we are dealing with tomorrow today. The present state of development never lets us rest. It is the latest progress in medical treatment that sets the pace.

In order to handle a variety of projects successfully and achieve a high degree of customer satisfaction, we have to improve our methods constantly.

In every accomplished project we see a new learning opportunity. Based on thorough process analysis, we make further adjustments. This continuous improvement resulted in our “Agile V”.

Standard requirements, approved procedures based on the V-model as well as the agile approach derived from software development have been combined to create an innovative development process.

At the end of every project, our customers are entitled to receive a product which meets all regulatory requirements.

Development processes?

The safe and swift track to your authorized product.

The base of our reliability is the Mechatronic method. Here we make use of our specific method skills. With the help of agile methods as well as innovative analysis and other work tools in our V-model, we meet even the highest demands. Our new “Agile V” allows us to leave the beaten path and create real benefits for our customers.

Within the product-prototype-cycle (PPZ), we realize mutually defined requirements to design a prototype. The entire development process is monitored by quality management processes and regulatory affairs. Finally, all testing and verifying activities are carried out within the product-prototype-cycle (PPZ).

The advantage of this method: easy access to reliable results and a real prototype to deal with. Our prototypes enable qualified requirement discussions by making them so much more concrete and efficient. Also, requests for adjustments can be realized swiftly in the on-going development of any given product.

On the fast track to success, to real hands-on results, and consequently to an authorized safe product. It is this method that convinces our customers. They really appreciate highly effective cooperation during the entire course of the project.

Customer requests?

Working within the customer-owned system architecture.

Companies focusing on medical engineering or diagnostics often work within their specialized development environments which have been designed and customized for their specific product portfolio over the years.

Naturally, they want to realize their projects in their own system environment. Our engineers are accustomed to act safely in any of these development environments.

Whether requirement engineering, software, mechanical or electronic development – or team is used to working on demand with the requirements and systems of our customers.

And they do so safely,
swiftly, and efficiently.

The Mechatronic advantage

Due to our own production, we know what the final product must be like.
Design-to-cost, design-for-manufacturing, design-for-reliability – we listen
to your demands and meet the requirements of your device.

Model-based development?

Reliable results from the get-go.

Systematic and efficient project management is based on the use of software systems for modeling. A document-based approach with the help of Excel-sheets and Word-documents does not even prove to be feasible for projects of medium complexity, simply because of the numerous combinations and interdependences involved. Document-based approaches most certainly fail whenever development results are required for new device generations in follow-up projects.

This is why Mechatronic has worked with model-based development for more than ten years without exception. Starting with the tender phase, we transfer the customer data into a system model. Thus, we are able to perform qualified discussions of our customers’ requirements right from the start.

This is how we link:

requirements

use cases

device behaviour

architecture

software design

test strategy

traceability

fault trees

document metadata

and much more

Our customers clearly profit from our method as opposed to document-based methods.

On the push of a button, they receive traceability and coverage analyses.
Risk management is included and self-consistent.
Redundancies are avoided. The terminology remains standardized and clear.
Data transfers requiring customer development tools are carried out reliably and efficiently. This goes for simple Excel-sheets as well as complex ALM-tools such as Polarion.
As a consequence, all results are consistent and traceable.
Regulatory authorization runs as smoothly as planned.

System concept?

Security comes first.

Good project results stem from well-oiled model-based development processes used as basic tools. The system and security concept of every new product is its pivot. This is where the product base is established.

The smart choice of an appropriate concept determines whether the final regulatory authorization runs as smoothly as the project itself. Only the best architecture ensures the project’s secure course. For this reason, Mechatronic has gathered its own team of system architects.

Employees equipped with long-term project experience, outstanding analytical and communication skills as well as excellent expertise in regulatory requirements form the core of every project team.

Production?

Keen-eyed and failure-proof

When you are done with development, production is just around the corner. For us at Mechatronic it’s more like a revolving door because we know the entire process from start to finish.

Twenty years of in-house manufacturing experience has equipped us with considerable know-how. We use it well and quite pragmatically – for the benefit of our customers. We transfer devices into production, establish the necessary environments and start the process according to the norms IQ, OQ, and PQ. ISO-13485 compliance guaranteed for international markets, no matter whether CE, FDA, Anvisa or CCC is applied.

Our claim to fame: ATE. Mechatronic operates more than 180 ATE stations worldwide. We know what to do in order to get devices to the market safely by carrying out all the required tests. Millions of devices by renowned diagnostics enterprises have been tested at ATEs run by Mechatronic. And they perform without failure to the present day. Our references are outstanding.

Made in Germany: Production in Germany means short supply chains and secure product supply.