"Unitron has found surprising solutions for the mechanical/electronic interaction separation of the modules. Through the project-based approach, the time pressure is never at the expense of skill.”
CD Leycom

Unitron Group

Your partner for medical and industrial innovations
“We have worked hard together with Unitron to make the overall manufacturing process more efficient with guaranteed quality.”
Orga

Unitron Group

Your partner for medical and industrial innovations
“Unitron has been chosen as partner, not only for the engineering but for the access to the future production of the medical device according to all ruling CE standards.
Vesalius

Unitron Group

Your partner for medical and industrial innovations
“Unitron has delivered valuable input in optimizing the design and selecting components and suppliers. Their communication is clear and open.”
Diagnoptics

Unitron Group

Your partner for medical and industrial innovations
“Unitron supports us in all aspects we need to get our first medtech product ready for the market. From improving the electronic design to making first production batches and from getting the right certifications to setting up logistics that is suitable for us. In short, an excellent supportive partner for us as a start-up company.”
Novioscan

Unitron Group

Your partner for medical and industrial innovations
“Unitron is always able to fulfil our requirements and their high-quality service contributes a great deal to the success of our own business.”
Dentsply

Unitron Group

Your partner for medical and industrial innovations

Unitron

Unitron is a manufacturer of high-quality medical and industrial appliances. Unitron is active on various markets worldwide as an innovative partner of leading quality-oriented market players. Unitron’s core activity is developing and manufacturing complex mechatronic and electronic appliances.

Insights

What about the MDR?

ISO 13485:2016, what about the MDR? Long awaited but finally there, and just in time before the end of the transition period of ISO 13485:2016, we have received our renewed QMS certificate! Again with the scope to design, develop, manufacture, distribute and service active medical devices, but now in compliance with the new version of […]

VACATURE ASSEMBLAGEMEDEWERKER

Voor onze productieafdeling in IJzendijke zijn wij op korte termijn op zoek naar een ASSEMBLAGEMEDEWERKER (V/M) Werkzaamheden: Je bent verantwoordelijk voor het zelfstandig samenstellen van elektronicaproducten. Je zorgt aan de hand van duidelijke werksets voor het voorbewerken, assembleren, monteren en testen van medische en industriële apparaten. Je bewaakt de productkwaliteit en zorgt voor het verpakken […]

Is your medical device ready for the new Medical Device Regulation?

Medical Device Regulation We are now in the final transition year for the new MDR regulation for medical devices that will go in force on 26th of May 2020. It is of general knowledge that, compared to the actual MDD directive, the regulation tightens significantly the demands for all participants involved in the bringing of […]

References

Unitron is convinced that investing in long-term partnerships with our customers contributes to the success for all parties.

Unitron’s proposition

Product

Our work always starts with a product idea, a prototype or sometimes even with a complete product from our customer. Unitron then coordinates the service package to the customer’s request. Unitron’s strong involvement with the product is best expressed by the term “product ownership”. The principal does however always retain the intellectual property.

Development

Unitron has a great track record in medical product development. We are a ISO13485-certified business; this knowledge is therefore fully embedded in the process. We of course also use this expertise in developing high-tech industrial products. Our areas of knowledge are in the fields of heat management, physiological and optical signal processing.

Engineering

A Unitron Process Engineer is closely involved in the project. He concentrates together with a Test Engineer on developing test assemblies, setting up the production process and training production staff. Our fixed frameworks here are the customer’s quality requirements, the specific product properties, legislation and rules. It is within these boundaries that we create product-specific work cells in order to efficiently create high-quality products.

Production

Unitron’s manufacturing concept is “Smart Production”. This involves maximum flexibility and minimum use of resources. A major plus point is that we can also achieve these properties with low production numbers.
We monitor production quality based on quality reports, workplace audits and periodic product reviews. These activities then lead to improvement actions.

Distribution

A good distribution system is essential for producing and entering the market.
We can send products directly to the end customer on demand. Unitron offers the possibility of warehousing in IJzendijke. Safety stock, end products or specific components that need to be purchased in larger numbers can be stored in our warehouse. Our customized logistics systems contribute to a flexible and punctual delivery of final products to the customer.

Service

We understand service as the maintaining of a product. This on one hand indicates necessary repairs and maintenance and on the other hand, our continuous improvement process.
Unitron is able to set up an RMA portal for customer repairs. The products can be registered and possibly returned from here. We will establish these processes in a service level agreement.

Business Development

Unitron is a stable and financially healthy business with an extensive international network. As well as relations with businesses, we maintain intensive contact with leading research and knowledge institutions. This leads to business opportunities for our partners and possibilities for developing new relations. We advocate an environment in which cooperation in sharing knowledge are central.

Certification

Unitron’s quality system complies with ISO 13485 and since 2014, the requirements of Japan (Ordinance 169) and the United States (FDA).
Setting up one’s own certification is a difficult and time-consuming task for many businesses. With a view to this, we offer customers the option of launching their products under the umbrella of Unitron’s quality system. The customer itself only needs to comply with a limited number of requirements for this.

Participation

Confidence is an important basic point in the cooperation that Unitron is seeking. Confidence in one another and in the product. Our participation is expressed in intensive cooperation and in the possibility of bearing the risks of a project together.

Product Lifecycle Management

The right Product Life Cycle Management enables us to keep a close eye on a product’s profitability and sustainable growth. In developing new product generations, we of course not only take into account the technical possibilities but also social developments, environmental effects and the continuing availability of the (scarce) raw materials.

Quality

Unitron has the following certifications: ISO 13485:2016 and Ministerial Ordinance 169. Our production department works according to the requirements of IPC-A-610D class 2.

At Unitron, both the Quality Assurance Department and the R&D Department have the relevant knowledge to guarantee the adherence to the laws and regulations.

Testimonials

  • Unitron was not only selected as a partner on account of its engineering but also for the access to the future manufacture of the medical device in accordance with all current EC norms.

    Vesalius
  • Unitron stood out a great deal due to a cost-effective, sophisticated and scalable approach to the manufacturing of a few units to a few hundred.

    Eaglet Eye
  • Unitron is convincing and displays a high level of quality and flexibility in organizing the manufacture.”

    IBA
  • We have worked hard together with Unitron to make the overall manufacturing process more efficient with guaranteed quality.”

    ORGA
  • Unitron is always able to fulfil our requirements and their high-quality service contributes a great deal to the success of our own business.”

    Dentsply
  • "Unitron has found surprising solutions for the mechanical/electronic interaction separation of the modules. Through the project-based approach, the time pressure is never at the expense of skill.”

    CD Leycom
  • Unitron has delivered valuable input in optimizing the design and selecting components and suppliers. Their communication is clear and open.”

    Diagnoptics
  • Unitron was able to come in at short notice when necessary with its expertise that goes a lot further than just assembly.”

    Dermasun Medical
  • Unitron has proven itself to be a reliable pleasant partner who shares our opinion to a great extent and is extremely flexible.”

    Edwards

Unitron Group info

Contact/ Feedback

Address

UNITRON SYSTEMS B.V.
Schansestraat 7-9
4515 RN IJzendijke
+31 (0)117 307 300

VAT NL 008197222B01
CoC 21015212

Address

UNITRON INNOTECH B.V.
Asveldweg 2
7556 BP Hengelo
+31 (0)117 307 300

VAT NL 808942669B01
CoC 08090157