Welcome to Nanogate Medical Systems

We are your skilled partner for the manufacture of high-quality plastic articles for medical technology. Our philosophy is simple: To do everything we can for you. Always with a view for the big picture and every important detail. We produce quality for your success and achieve more than you may expect.

BENEFIT FROM OUR EXPERIENCE, TOO!

Development

In order to turn your product idea into reality, take advantage of our experienced developers and designers of state-of-the-art 3D-CAD tools and simulation software. This is how we ensure that your vision is optimally implemented across the entire process chain.

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Production

Outstanding product knowledge and ongoing investments in our modern machine park offer the best technical prerequisites for your requirements in the locking pressure range from 50 kN to 800 kN.

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Quality

Quality knows no compromises at Nanogate Medical Systems. The safety of patients and users is our top priority. We therefore ensure you the highest level of quality.

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Product development with our expertise

Do you have an idea for a product or are you searching for the solution to a medical technology problem?

Our team stands at your side with our experience and creativity to support you at all stages of your value chain from the product idea through initial prototypes all the way to series production, packaging and delivery.

Along with the project manager, who supports you throughout the entire project, employees from design, quality assurance and manufacturing belong to your team.

With state-of-the-art CAD tools and simulation software, we screen the product from the beginning and optimize wherever necessary. This ensures that we fully achieve your vision.

We keep an eye on costs and aim for the highest quality in every step throughout the process to work with you in creating an economically successful, premium product.

Do you still have questions? We would be pleased to help you!

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Production according to the highest standards

Comprehensive Perfect Production

From our more than 30 years of experience in medical injection molding, we know exactly what we are doing. We have impressive expertise in all areas of silicon processing for the medical field (LSR, silastic). Our expertise in the processing of high-quality thermoplastics (PEEK) and thermoplastic elastomers (TPE/TPU/PUR) makes us a highly skilled partner for you.

The continuous improvement processes in production, outstanding product knowledge, insights into applications and ongoing investments into state-of-the-art manufacturing techniques have made us a quality leader in medical technology. Our multifaceted machine park in Kierspe offers the best technical prerequisites and covers the locking pressure range from 50 kN to 800 kN. We are also big on a small scale: Our micro-injection molding offers you a final part weight of less than 0.6 grams! All injection molding processes are continuously monitored and recorded using SPC.

Our production site combines expertise with state-of-the-art manufacturing for diverse requirements of medical technology. At this location, Nanogate Medical Systems offers you the highest quality and absolute product safety. Integrated quality management and our product testing – which can also be carried out according to special customer requirements – provide you with this guarantee.

In terms of customer service, too, we are always on the move. With the expertise of our highly motivated team and the adaptability of our production, we create the ideal prerequisites for addressing your economic and ecological issues. Short decision paths are a further guarantee for just-in-time manufacturing. Benefit from our many years of experience and our innovative spirit for the best results. We can find a solution – even for your demanding requirements. True to our working motto: “The customer must return and not the product!”

Highest Quality

Whether an annual requirement amounts to a few hundred parts or we manufacture millions of articles per year, maximum quality, flexibility and customer service are the most important pillars of our customer relations

30 Years of Experience

The Nanogate Group’s vast experience in plastic processing speaks for itself! In the area of medical technology, you can rely on a team with 30 years of experience in the development, design and processing of all popular thermoplastics and silicons.

Cleanroom Production

The records of all relevant parameters of cleanroom production are so precise that they can be used for GMP-compliant documentation. Nanogate Medical Systems thereby offers its customers an absolute maximum of production safety and quality.

We aspire to the highest quality

The Highest Quality Knows No Compromises

The safety of patients and users is our top priority. We therefore ensure you the highest level of quality. Since precise and sterile working procedures are essential in medical technology, all our products are manufactured and packaged with the highest degree of care and subjected to strict tests.

They include microbiological analyses to monitor germ load, the routine quantitative determination of bioburdens in accordance with DIN EN ISO 11737 as well as biocontamination controls (contact plates) for the screening of the germ load of airborne particles. If required, we also offer a Limulus amebocyte lysate (LAL) test, kinetic-turbidimetric method, in accordance with USP <85>.

In addition, we conduct any packaging of products under cleanroom conditions. Our cleanroom satisfies the requirements of ISO Class 8/ISO Class 7 in accordance with DIN EN ISO 14644-1.

Following successful certification in accordance with ISO DIN 9001, our internal quality management system governs all procedures and processes. We also do not know any compromises in quality safety and use a variety of test methods:

Additional Test Methods

  • Leakage testing
    • In bar under water with a hermetically sealed system as well as with a water-filled system 0–2 bar
    • Measurements in an airtight system in the range of 0–3000 Pa
  • Torque testing 0–200 Ncm
  • Tension/pressure testing in the range of 0–2000 N and 0–700 mm
  • Digital hardness testing Shore A
  • Measuring projector for optical measurement
  • CNC-3D measuring machine optical and tactile
  • CAQ system for SPC monitoring and test plan management
  • Color measurement technology
  • Computer tomography for measurement, validation and component testing

As specialists for medical injection molding we can satisfy the high precision requirements for individual components at any time. For example, tolerances of ± 0.02 mm are the standard for us in injection molding.

Complex Assemblies

Components manufactured by multi-component injection molding, metal inserts, assembly injection, or by pure handwork. Our entire team is always close to the product and monitors all manufacturing steps, not only with in-process control. We also take into account legally required documentation.

CAQ System Process-Wide

Since 2008 the CAQ system of the Böhme&Weihs company has been an integral component of quality documentation at the Nanogate Group. A consistent and reliable system from incoming goods testing to SPC batch production monitoring and batch traceability all the way to the shipment of outgoing goods!

Functional Testing

Already during advance quality planning, we coordinate with you to determine the required tests, which we conduct ourselves in-house.
Leakage controls, tension and pressure testing, as well as dimensional and weight monitoring are thus seamlessly integrated into the documentation and are already provided upon delivery at the customer’s request.

We take your success personally

With Nanogate Medical Systems a dynamic team stands by your side that successfully takes care of your order from beginning to end. You decide whether your requirements and our team match up well. We offer you what we can do best: the constructive interplay of committed people, special skills and significant experience.

Direct point of contact

Axel Schuchmann

CEO

Phone +49 2359 50809-60
Fax +49 2359 50809-80
axel.schuchmann[at]nanogate.com

Ralf Erlhöfer

Plant Manager

Phone +49 2359 50809-70
Fax +49 2359 50809-80
ralf.erlhoefer[at]nanogate.com

Paul Giesbrecht

Head of Quality Management

Phone +49 2359 50809-77
Fax +49 2359 50809-80
paul.giesbrecht[at]nanogate.com

Gabriele Rüth

Quality Reliability

Phone +49 2359 50809-64
Fax +49 2359 50809-80
gabriele.rueth[at]nanogate.com

Ulrike Stevens

Production Planning

Phone +49 2359 50809-63
Fax +49 2359 50809-80
ulrike.stevens[at]nanogate.com

Margit Schulenburg

Purchase

Phone +49 2359 50809-61
Fax +49 2359 50809-80
margit.schulenburg[at]nanogate.com

Our values

Goal-oriented behaviour, ambitious implementation – according to this guiding principle, we work and communicate in the company.
We believe in the meaning and importance of behaving according to ethical principles and we are always committed to the highest standards of business conduct. This is the basis of our business values.

Performance – Sustainability

Performance – Sustainability

Our aim is an efficient and performance-oriented manner of working, without losing sight of the whole. This means profitable growth and responsible action towards all possible stakeholders. The company does not target a quick profit, but would rather have long term success.

Motivation is a driving force for our actions, but always in the sense that “efficiency and ethics are not mutually exclusive.” The commitment to sustainability and the responsible use of resources is part of our corporate strategy.

Openness – Respect

Openness – Respect

We advocate for open and honest communication. This also includes the courage to address unpleasant things. Openness must not lead to disrespect; rather, it represents a constructive, cause-oriented “culture of debate”.

In heated discussions, respect is always maintained. Within the company, respectful dealings with each other and with our customers are maintained. This means the positive evaluation of a person as a whole, but also his or her thoughts, work and behaviour. Openness also means being willing to change in light of new developments.

Quality - Personal Responsibility

Quality - Personal Responsibility

Quality is essential and given top priority in our actions, our products and processes. We want excellence for our customers. But quality is not an end in itself, because it may lead to a control culture and overregulation.

Each individual has a responsibility for what he or she does. The sight of the bigger picture, the willingness to make decisions and to take responsibility for them are important principles. Energetically working within a reliable framework – with this we can achieve something extraordinary.

Change – Reliability

Change – Reliability

Change is a central cultural feature of Nanogate. We find ourselves in a permanent process of change. This is accompanied by the aspiration towards excellence. Change is characterized by goal-orientation, alacrity, decisiveness and a culture open to mistakes. Important sources for our will to change are our openness and creativity.

On the other side of the coin is the striving towards reliability. Reliability includes appreciative and reliable behaviour towards all known stakeholders (stakeholders: employees, customers, shareholders, etc.). An example of this is the clear and unambiguous formulation of our corporate values, which should give the people at Nanogate orientation for their actions.

Target-Orientation – Creativity

Target-Orientation – Creativity

We are determined and performance oriented, but without exaggerated doggedness. We take account of the human component as well the fun side of things. Here creativity and spontaneity are important drivers that support our innovation and lead to new ideas and positive changes.

We have the corporate purpose and our goals clearly in mind. We expect all employees to actively participate with process improvement and contribute their experience and ideas to the company.

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Our address

Nanogate Medical Systems GmbH
Osemundstraße 27 – 29
58566 Kierspe
Germany

Phone +49 2359 50809 60
Fax +49 2359 50809 80
info-medical@nanogate.com