OUR MOTIVATION

We want to develop technologies that enable all hydrocephalus patients worldwide to live a normal life.
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OUR VISION

Since 1992 we have been developing and producing neurosurgical implants, especially for the therapy of hydrocephalus. In addition to the fact that the research and further development of medical products is a highly responsible and meaningful work, we are primarily driven by a common vision: We want to develop technologies that enable all hydrocephalus patients worldwide to live a normal life. Every step in this direction is the right one and drives us to continue with further research, to make products even better and to question solutions again and again.

OUR PHILOSOPHY

The human being is at the focal point of each human activity. In connection with the Christoph Miethke GmbH & Co. KG, that means all the people we are directly and not directly connected with. Our corporate philosophy says: Human dignity is inviolable. And that is what we live. A key element of respect and a dignified harmonious atmosphere is the balance of closeness - based upon interest - we want to share with each other. Feeling, creating and living closeness combines many facets of social values with one end in view: a social living space where everybody feels in good hands and meet on equal terms.

At first, this means the affected patients. We strive to improve their life situation with innovative developments and the production of high-quality and reliable products. For them, we want to be a competent open minded contact partner for all questions around our products and their worries with it. We maintain close contact with international neurosurgeons to gain new experiences and to use it.

It means our employees as much as each other partner we work together with.

That builds trust and closenes. And that builds - as by itself - a special responsibility for quality and the creativity that is needed to create innovations.

OUR MISSION

We are passionate about researching and developing unique and innovative product solutions, and in doing so we constantly question the status quo. We listen carefully to our partners, neurosurgeons and patients as well as to each other in order to learn and allow room for ideas. 

 We are aware of the importance of our work for patients' lives and share this responsibility. On this basis, we apply the highest standards of quality and safety when manufacturing our products.

OUR

values

INNOVATION

Over the last 50 years, no other company has developed and launched as many technological innovations for the treatment of hydrocephalus as MIETHKE. In line with our vision of one day be able to offer ALL hydrocephalus patients a solution that improves their quality of life despite the variety of requirements, we will not stop here.

Science

Cientific work is a matter of principle for us if we want to produce innovations in a scientific context such as medical technology. This makes it even more important in the field of hydrocephalus, which is still comparatively under-researched and sometimes unattractive for doctors. We see ourselves as a scientific partner in cooperation with many scientific and clinical institutions on an equal footing. Science and innovation are created by sharing knowledge and thinking together.

Quality

Our aim is to develop products that exceed the state of the art in terms of functionality, safety and quality. For us, quality is not just a production parameter but the result of an awareness of responsibility and humanity. In an emergency, we all want to rely on the people on whom we depend to give their best.

Responsibility

As a manufacturer of medical devices, we bear a great responsibility for the functionality, safety and quality of our products and we know that. However, our responsibility does not end with product safety. We face up to the feedback from our critics. We take responsibility as a democratic member of our society. We comply with applicable laws. We always communicate clearly, respectfully and at eye level..

Closeness

Knowledge and innovation arise when you deal with issues, allow closeness, know concerns at first hand and can withstand criticism. We seek closeness to doctors, scientists, patients and relatives and offer it to all interested parties, provide answers and look for solutions together. Closeness has always enriched us and is human and meaningful for us.

OUR QUALITY POLICY

As a manufacturer of neurosurgical implants and against the background that we bear a great responsibility with our work, quality is not just a word but a daily routine.  We orientate all processes and activities to the best possible quality standards and a comprehensive quality management system, which is continuously developed further in accordance with the growing requirements.

Furthermore, it is our own endeavour to always overcome the state of the art phenomenologically in terms of functionality, safety, product quality and ultimately quality of life for affected patients. All products delivered by us comply with the declared specification of our validated quality assurance system already during development and in the execution. Within the framework of a qualified logistics chain, we also ensure that partners and suppliers meet our high standards of quality and safety.

CERTIFICATES

Our products are distributed in many countries around the world. The quality requirements of the Japanese Ministry of Health and Welfare (MHW Ministry of Health and Welfare) are as familiar to us and integrated into our quality management system as those of the US Food and Drug Administration (FDA). The company is regularly inspected by various auditors from different countries. We welcome customers and interested institutions to visit us at any time.

RELEVANT INFORMATION

Our EC-Certificate according to the Council Directive 93/43/EEC (MDD) on Medical Devices expired on 2024-05-26. But we have made use of the extended transitional period for MDD "Legacy Devices" in accordance with Regulation (EU) 2023/607.

Our MDD-compliant legacy devices may therefore be legally placed on the market with CE marking until 2027-12-31 (for our implantable Shunt Systems) and 2028-12-31 (for our Instruments), respectively.

Instead of a new EC-Certificate, we have issued a Manufacturer’s Declaration concerning the extension of the MDR transitional period. In addition a Confirmation Letter by our Notified Body (European Authority) is available on request.

 

 

Certificate EN ISO 13485

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Certificate 93/42
valid with Manufacturer’s Declaration


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Manufacturer’s Declaration

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 (MDR) EU Quality Management
System certificate

(Annex IX Chapter I)

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REACH Declaration

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Diversity Statement

Human dignity shall be inviolable. This is not only the first sentence of the German constitution, but also the core of our corporate philosophy. This goes hand in hand with our clear view that every person, with all their different facets that make them exactly who they are, deserves the same degree of openness and respect. Consequently, the topic of diversity is an essential concern for us - out of firm belief, which is strongly anchored in our daily actions & cooperation. Accordingly, we also try to use gender-neutral wording in any communication in which it appears sensible and feasible. In case we do not succeed in doing so, this does not alter our inner conviction. At the same time, we would be pleased to receive suggestions in this regard in order to express our belief in our wording.

 

Our DIVERSTY Statments

Diversity is important and good. Our employees also appreciate that:

OUR PARTNERSHIP
WITH B. BRAUN

B. Braun and MIETHKE - Together for a better life with hydrocephalus

We have a long and intensive partnership with B. Braun in the field of neurosurgery. We are driven by a common vision: to improve the lives of hydrocephalus patients around the world with innovative solutions.

Our partnership is an exciting combination of B. Braun's nearly 180 years of expertise as one of the world's leading medical device and pharmaceutical companies and our agility as an innovative company and technology leader in gravitation-based shunt technology.

 

Our strong partner in neurosurgery:

www.bbraun.com