Who we are and what we do

em-tec GmbH was founded in 1988 near Munich. Since this time we have developed and produced successful products approved for medical technology as well as for industrial use.

We combine technological, biological and medical expertise, develop coherent solutions and guarantee our customers innovative and economical products.

From the first idea to the market – we are the ideal partner for all steps of product development. We also have our own in-house production. This is solid quality „Made in Germany“.

We are certified according to the standard for medical device manufacturers (ISO13485). Read More about the Quality Management System…

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Our team

Specialists at Work

  • Everything starts with passion at em-tec
  • It drives us to continually implement innovative ideas at the highest level
  • Enthusiasm for joint projects turns our team into a strong unit where every opinion is valued
  • It is only when expertise, highly professional processes and work enjoyment are united that we can shape the future together
  • And we continually seek to develop and improve our own processes, resulting in new ways to manufacture more efficiently and to achieve higher and higher quality standards

Valid Jobs

Job Vacancies

Looking for a new challenge and want to bring your knowledge in a dedicated team?

We are constantly looking for motivated colleagues.

Current job vacancies in Germany

Quality Management System

Process-oriented quality assurance is our priority number one!

We manufacture and develop medical devices and assessories, such as high-quality components for heart-lung machines, dialysis machines, flow measurement systems, cardiac support systems and industrial flow meters, e.g. for the  bioprocessing technology. We offer medical devices under our own brand, but we are also OEM supplier and thus an important partner of numerous large medical technology companies. The contract development for medical devices is one of our core competences, therefore we are very familiar with the regulatory requirements in medical technology. Our quality management system is certified according to ISO 13485 and also meets the requirements of the 21 CFR 820 (GMP, US-FDA).

We commit ourselves to the highest quality standards for our products and services through our quality management system. Our daily mission is to provide competent advice and correct order processing for our customers and users taking into account state-of-the art and future legal requirements, standards and guidelines!

 

Our QM system complies with the following standards:

  • DIN EN ISO 13485:2012 (certified by TÜV Süd)

Click here for checkmark reference

This ISO standard is detailing the requirements for a comprehensive management system for the design and manufacture of medical devices.

  • EU Directive 93/42/EEC (certified by TÜV Süd)

This medical device directive is the most important regulatory instrument for demonstrating safety and medical as well as technological functionality of medical devices within the European Economic Area.

  • EU Directive 2014/30 EU

This directive specifies how the electromagnetic compatibility of electrically operated devices in the European internal market is to be achieved.

  • EU Directive 2011/65/EU (RoHSII)

The directive RoHS II is intended to limit the use of certain hazardous substances in electrical and electronic equipment and regulates the use and the placing on the market of hazardous substances in electrical appliances and electronic components.

  • 21 CFR 820 (GMP, US-FDA, Qualitätssicherung)

Requirements for the quality management system of manufacturers of medical products, exporting to the USA (good manufacturing practice for medical devices/GMP).

  • NRTL current  (Inspections by TÜV Süd)

NRTL inspections for USA and Canada.

  • J-QMS (Confirmation Letter)

Regulatory requirements for manufacturers of medical devices for the Japanese market.

 

We use the Application Life Cycle Management Software ToolPolarion“ to support development, verification, requirements management and documentation.

No success without strong sales

Europe

em-tec GmbH

Lerchenberg 20
86923 Finning

+49 8806 9236 0

sales@em-tec.de

USA

(Products & Components
Flow Measurement)

em-tec Flow Technology Inc.

14 Pennsylvania Plaza, Suite 1800
New York, NY 10122, USA

+1-607-303-0737

info@emtecflow.com

International Cooperation
(Flow Measurement
on Human Vessels)

Medistim ASA

Økernveien 94
0579 Oslo, Norway

+47 23 05 96 60

Since April, 1st, 2016: all sales related questions with respect to flow measurements on human vessels have to be directed to Medistim or its distributors.

Hong Kong / Macao
(SonoTT™)

Shun On Healthcare Limited

Unites 3101-3109, 31/F Standard Chartered Tower
Millenium City One 388 Kwun Tong Road
Kowloon, Hong Kong SAR

+852 3123 8000

info@sohealthcare.com