seleon gmbh of Heilbronn at COMPAMED 2019 in Düsseldorf -- MEDICA - World Forum for Medicine
Premium Exhibitor Manufacturers Service

seleon gmbh

Im Zukunftspark 1, 74076 Heilbronn
Germany
Telephone +49 7131 2774-0
Fax +49 7131 2774-100
info@seleon.de

Hall map

COMPAMED 2019 hall map (Hall 8b): stand G05

Fairground map

COMPAMED 2019 fairground map: Hall 8b

Contact

Harald Genger

Geschäftsführer

Phone
+49 7131 2774 0

Email
info@seleon.de

Fabiola Hartung-Linz

Sales Coordinator & Marketing Manager

Phone
+49 7131 2774 40

Email
fabiola.hartung-linz@seleon.de

Andreas Happold

Sales Director

Phone
+ 49 7131 2774 0

Email
andreas.happold@seleon.de

Dr. Stefan Fiedler

Director Business Development

Phone
+49 7131 2774 0

Email
stefan.fiedler@seleon.de

Benjamin Klein

Director Business Development

Phone
+49 7131 2774 0

Email
benjamin.klein@seleon.de

Visit us

Hall 8b / G05

18.11.2019

Topic

all-day

MATCHPLAYER WANTED

MATCHPLAYER WANTED
https://www.seleon.de/en/career/careers-with-seleon.html

More Less

19.11.2019

Topic

all-day

MATCHPLAYER WANTED

MATCHPLAYER WANTED
https://www.seleon.de/en/career/careers-with-seleon.html

More Less

20.11.2019

Topic

all-day

MATCHPLAYER WANTED

MATCHPLAYER WANTED
https://www.seleon.de/en/career/careers-with-seleon.html

More Less

21.11.2019

Topic

all-day

MATCHPLAYER WANTED

MATCHPLAYER WANTED
https://www.seleon.de/en/career/careers-with-seleon.html

More Less

Our range of products

Product categories

  • 01  Manufacturing of components
  • 01.01  Electronic manufacturing services (EMS)
  • 01.01.02  Electronics development

Electronics development

  • 01  Manufacturing of components
  • 01.08  Rapid prototyping

Rapid prototyping

  • 01  Manufacturing of components
  • 01.09  Other component manufacturing

Other component manufacturing

  • 02  Manufacturing of finished products
  • 02.09  Electromedical devices

Electromedical devices

  • 02  Manufacturing of finished products
  • 02.10  Endoscopes

Endoscopes

  • 02  Manufacturing of finished products
  • 02.12  Dental products

Dental products

  • 02  Manufacturing of finished products
  • 02.13  OR infrastructure

OR infrastructure

  • 03  Services
  • 03.02  Consulting (services)
  • 03.02.03  Education, training

Education, training

  • 03  Services
  • 03.02  Consulting (services)
  • 03.02.04  Regulatory affairs

Regulatory affairs

  • 03  Services
  • 03.02  Consulting (services)
  • 03.02.05  Documentation

Documentation

  • 03  Services
  • 03.02  Consulting (services)
  • 03.02.06  Clinical trials

Clinical trials

  • 03  Services
  • 03.02  Consulting (services)
  • 03.02.07  Medical device approval

Medical device approval

  • 03  Services
  • 03.04  Design and development
  • 03.04.01  Product design, product development

Product design, product development

  • 03  Services
  • 03.05  Assembly

Assembly

  • 03  Services
  • 03.09  Testing services
  • 03.09.05  Certification

Certification

  • 03  Services
  • 03.09  Testing services
  • 03.09.06  Auditing

Auditing

  • 03  Services
  • 03.10  Other services

Other services

  • 04  Manufacturing equipment
  • 04.11  Quality assurance
  • 04.11.03  Measuring technolgy, testing technology

Measuring technolgy, testing technology

  • 06  Electrical components, electronical components
  • 06.07  Embedded systems

Embedded systems

  • 09  Software, IT
  • 09.03  Software development

Software development

  • 09  Software, IT
  • 09.04  Software as a medical product

Software as a medical product

Our products

Product category: Clinical trials

CRO: No risk more fun

Clinical Investigations and Studies within medical technologyAs part of the pre-market obligations for medical devices, the clinical approval constitutes a highly cost-intensive and time-consuming process. In-depth clinical evidence on the safety and performance of a medical device as well as its positive risk-benefit ratio must be yielded and presented within the clinical evaluation. Clinical evaluations based on data on similar products that has been published and made publicly available are less and less often acknowledged. The demands made on the quality of clinical data as well as the comparability with one's own medical device have tremendously increased since the MEDDEV 2.7/1 rev. 4 was introduced. In times past clinical studies constituted an exception for the majority of medical devices to be approved, in future they will be required far more often. Also the request for Post Market Clinical Follow Up Studies will increase, addressing indication related technicalities or securing performance demands.

Performing clinical investigations demands a well-established network and detailed knowledge on the actual realisation:
Which design and sites of study are best suited for your defined goals? How many study participants are needed? Which endpoints does the clinical study have? These questions will be answered during thorough study planning and preparation. Project management, monitoring, data management and statistics are only a few of the several tasks to be accomplished.

More Less

Product category: Regulatory affairs

NO RISK APPROACH

Regulatory Requirements in Medical TechnologyThe continuous changes and amendments made to the rules and regulations for approving medical devices demand highest attention and constant updating of one's knowledge level. For remaining competitive in the market, manufacturers need to be equipped with profound knowledge of all applicable rules and standards and apply them appropriately and traceably.

Medical device approval is complex.
The range of services and knowledge built around the topic "Regulatory Affairs" is broad and bears on numerous different directives, laws, regulations and standards. At the same time the internationalisation results in a diversity of country-specific regulations with clear differences.

The core issues of this area are amendments made to products, labelling of the same, and tests prior to market introduction. Establishing and maintaining technical documentation that complies with the Medical Device Regulation (MDR), additional CE Directices, if applicable, and also fulfills the slight differences relevant for international approvals. At this both the requirements of the US Food and Drug Administration (FDA) and the Medical Device Single Audit Programs (MDSAP) occupy a special place.

More Less

Product category: Product design, product development

Impossible is nothing

PRODUCT DEVELOPMENT
seleon "rock solid medical engineering made in Germany" has a clear objective:

we transform your ideas into products at the pinnacle of medical technology  development. Our customers benefit from our many years of industry experience and our comprehensive process and methodology know-how. For housings and carriers, controllers and sensors, valves, mixers, compressors, fans, pumps, software and much more.

You have access to all specialist departments required for the development of complex medical technology systems. The specialised knowledge of our interdisciplinary development team is available to you throughout the entire product development process – from conceptual design to the development of functional models and prototypes to approval and the transfer to series production.

By bundling all process steps for a project, our customers can realise crucial cost advantages while saving time and ultimately obtaining the best possible result for market success

More Less

Product category: Other component manufacturing

From zero to infinity

Production
As an assembler, all of seleon’s know-how depends on its employees. All components, test equipment and tools required for assembly are supplied to seleon, where they are assembled into the desired new products.

The synergies of close coordination between development and production are realised in the fabrication of highly specialised devices, produced mainly for the medical technology sector. But since seleon has experience with highly precise technical specifications, we also meet the requirements to serve as a partner in other sectors such as the aerospace industry.

More Less

Company news

Date

Topic

Download

Sep 10, 2019

Harmonised Standards unter the MDR

The European authorities and institutions still have to work elaborately on the harmonisation of standards under the Medical Device and In-Vitro-Diagnostics Regulation. Before we try to provide a prospect on further instruments for proof of compliance, we first would like to answer the question of what harmonised standards are and why they are necessary. Also, what recommendations for action apply to manufacturers of medical devices in the current situation, some of which have not yet been clarified.

More Less

About us

Company details

ONE STOP SHOP
seleon gmbh - rock solid medical engineering - made in germany.

seleon is one of the leading engineering and manufacturing providers in the medical device sector with 21 years´ experience. We offer, with our one-stop-shop a wide range of applications complete device development, quality and process management, regulatory & clinical affairs, international product certification support and production transfer.

Our customers - ranging from small and midsize enterprises to large corporate groups - benefit from this expertise.

More Less

Company data

Sales volume

10-49 Mio US $

Export content

max. 10%

Number of employees

100-499

Foundation

1998

Area of business
  • Manufacturing Services
  • Services

Company information as a PDF file