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You are looking for an introduction to various topics of medical device development or want to get a first impression of our work?
Here we would like to provide you the opportunity to benefit from our experience.
In our white papers, we would like to show you practical solutions for dealing with the current challenges in medical technology. In doing so, we draw on the extensive experience we have gained from our work with customers.

Risk Management

Risk management is complicated?
It doesn’t seem worth the effort?
For many companies, risk management is a difficult task that is often bypassed or neglected.
However, without proper risk management, you are not only putting your product’s approval at risk, but so is patient health.
This white paper is designed to empower you to grasp the basics of risk management and put them to work for your company. 

Product development with external development partners

Do you really have to do everything yourself?
For many managing directors, the realization comes too late that their company cannot implement everything itself that is now required in the development of medical technology.
The MDR only reinforces this signal. As a decision-maker in your company, you may let go of things that other companies can produce more efficiently and more cheaply than you.
How you can find a suitable development partner and what advantages you can gain from this is made clear in our white paper.

Supplier Management and product liability

Gone are the days when the various responsibilities of distributors, manufacturers and suppliers in medical technology were not clearly regulated.
Now the responsibility has finally been placed in the hands of the manufacturers.
Many manufacturers are currently finding major gaps in their supplier management, which will require a great deal of effort to close.
However, if they fail to do so, their products may lose their certification in the following years and have to be withdrawn from the market.
How you can counter this risk is outlined in our white paper.

Requirements Management

The product is not accepted on the market and the development fails to achieve its goals?
Requirements management is one of the most important processes in the development of medical technology. If requirements for the product have not been fully gathered or defined with sufficient specificity, there is a high risk that the product cannot be brought to market or that major difficulties will arise during the market phase.
How to get your requirements management on track and overcome the aforementioned hurdles is described in this white paper.

Product development in medical technology

Developing medical devices now costs five times as much money and with a tripling of the time required than 10 years ago. Added to this are the stricter regulations of the MDR. For these reasons, many companies are reluctant to develop new products.
Our work with Berlin Heart shows that product development can be successful despite the hurdles. Together, we were able to develop and successfully certify a product on time and within budget.

Process validation

The production of medical devices always includes a large number of processes that must be validated in order to meet the requirements of ISO 13485.

Process validation therefore plays an important role in the production of medical products. Yet companies are often unaware of the actual scope of #processvalidation.

Our white paper describes everything that needs to be considered in process validation and how comprehensive implementation can succeed.

Transition from MDD to MDR

Many companies see the MDR as an unnecessary burden and oppose the new legislation. However, the fact that these companies need the MDR to be able to assert themselves in a changed, digital market is not taken into account.
Read our white paper to find out how the transition from MDD to MDR can go smoothly.

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