Medical Products Supplies Companies

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

Product Categories

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.

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.

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

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.

ad: contact information

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.

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

ad: company