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BIEGLER Medical Electronics gives you all these skills and services you need, to turn an
interesting product idea into a sales-ready and CE-marked medical product.
As your development partner, we handle all the work from the initial design stage right
through to sales-ready product. Put this turnkey service and our many years of experience
together, and we can bring your product to market quickly and cost-effectively.
BIEGLER Medical Electronics doesn't just provide all the following services from one
source: We do it all in house also. And we have special skills such as sterilization
covered, in conjunction with our trusted, long-term partners.
> Research and development
> Product approval
> Design and build
> Production in metal and plastics
> Electronics manufacture and device assembly
> Manufacturing and packing in the clean room
> Quality management
> Sales and marketing
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Research and development
Working with the customer at the outset: research and development is one of the core
competences of BIEGLER Medical Electronics. Highly qualified, experienced product
developers work on the entire range of project tasks, from initial design right through
to transfer to mass production.
BIEGLER Medical Electronics develops complex medical products. To do this, we make use
of our many years of know-how, e.g. in the areas of metal, plastic, mechanics, pneumatics
and electronics. In this regard, our strength lies in our ability to integrate different
skills and technologies.
When it comes to product development, we attach great importance to the fact that we
combine customers' medical expertise as early as possible with our own medical products
creation expertise. We find that, once the initial stages of a project are completed in
this way, the results are cost savings and the shortest possible time to market.
By the way, you will also find that we really put the "R" in research: Down the years,
we have maintained great contacts with research and development departments at Austrian
university hospitals and specialized research institutes.
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Product approval
Not only do we meet all the technical requirements to bring a medical product to market,
we also make sure that all the relevant regulatory requirements are met. Since 1994,
BIEGLER Medical Electronics has implemented a quality assurance system and is certified
to the EN ISO 13485:2003 standard. We
handle the entire medical products approval process. In the past, we have successfully
ensured that products have been approved as class 2B or CE-designated.
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Design and construction
Our product design capability is specially configured for medical products. In this
connection, we pay attention not just to aesthetics, but also to ergonomics,
functionality, hygiene, and user- and servicing-friendliness. We meet the highest
standards in all these respects; and this is illustrated by the fact that we have been
awarded the Austrian State Prize for Good Design, as well as a whole series of other
prizes.
Our construction department builds the bridge to actual production, turning high value
design into production-ready manufacturing. We can work with all current data formats
(e.g. dwg, STEP, IGES and dxf) and also have a visualization capability, e.g. using 3D
Studio VIZ.
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Production in metal and plastics
BIEGLER Medical Electronics performs all the necessary mechanical manufacturing steps
in-house, from prototype manufacture (design model) right through to creation of an
entire device series.
The wide range of products we have worked on means we have been able to develop a superb
infrastructure:
CAD/CAM workstations, CNC milling machines (with up to four axes), remote-controlled
milling machines, a CNC lathe complete with rod loader, a lathe especially developed for
unusual threads, conventional lathes, a finisher, a grinding machine, welding devices and
sheet metal working machines (e.g. hydraulic press, edger). Our device construction
capability enables us to manufacture efficiently and in-house the machinery needed for
production automation.
We also have the capability to perform plastics injection molding and to make our own
molds. We have a controlled zone, where we process all current thermoplastics using
machines with pressure capabilities of 25-200 to.
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Electronic manufacturing and device assembly
One of our main strengths is the manufacture of SMDs and conventional prints: Components
are procured, equipped using lasers, soldered, given an intermediate check and
pre-adjusted. We also manufacture cables and can assemble devices. We attach massive
importance to safety and other final checks.
We always make sure that our customers' service technicians and customer support staff
are thoroughly trained in the use and maintenance of the devices we produce.
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Manufacturing and packing in the clean room
Our 100,000 class clean room is used to manufacture and pack disposable plastic products.
As system partners, we also offer sterilization of products using steam, EtO or gamma
radiation; and we call on trusted partner contractors for this purpose.
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Quality management
Our products are known for their safety and reliability. The standard we set for the
quality of our products is the total satisfaction of our customers, whereby the main
principle we work to is continual improvement in all respects. Whenever we implement
improvements, we always regularly check their effectiveness.
The medical products market is subject to stringent regulatory requirements around the
world. Since 1994, we have been implementing our quality management system and are
certified according to the EN ISO 13485:2003 standard.
We regard this practice as a guarantee of uniform high-quality
for all our processes, from development right through to service.
We maintain constant, close contacts with our customers. This closeness to our market,
enables us to make sure products are always cutting-edge.
Our work is governed by the principle that our products should serve the well-being and
health of people everywhere.
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Sales and marketing
We have more than just technical capabilities to offer. Our sales and marketing
department supports our distributors in every way. For example, we can supply contacts
among opinion makers, so that our products can benefit from a strong medical and
scientific foundation. We also provide all the necessary means of communication.
Our marketing department has solid experience and a network of market analysts. This
means that it can analyze the commercial viability of your product idea and can advise
you regarding the strategic positioning of any product.
Our closeness to the market is your guarantee of market-appropriate innovation.
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