ISO 13485

CUSTOMER-ORIENTED SYSTEM SOLUTIONS FOR MEDICAL DEVICES FROM A SINGLE SOURCE.

In order to offer the medical device manufacturers among our customers even more security in accordance with international standards, we extended our existing quality management system according to DIN EN ISO 9001 in 20012 by the requirements of the standard for medical devices.

OMNITRON is therefore a special partner for medical device manufacturers, one who can meet all quality, documentation and traceability requirements with certification in accordance with DIN EN ISO 13485.

A dedicated risk analysis and evaluation of the “mobile power supply” component is one of our extensive services within the scope of packaging in accordance with DIN EN ISO 13485.

The selection of qualified pre-suppliers, high-quality materials and preliminary products is another essential component of our quality management system.

In accordance with our certifications, we document the individual tests during production.

The test certificate and declaration of conformity provide information on the conducted tests and results and confirm the conformity of the end product with the specified properties of the individual components.

We would be happy to show you which standard is suitable for your medical device during a visit to your premises. Or you can visit us at our production site and get to know our qualified assembly live.

ABOUT US

Are you looking for the technically best battery solution at the best possible price? Then Omnitron is the right place for you. Thanks to our many years of experience, we are able to develop exactly the right product for you. We also advise you on the appropriate charging technology and develop it exactly according to your individual wishes.

HOW THIS WORKS?

Our technically experienced sales force advises you individually on site. Subsequently, our employees in project planning and development develop the best and most economical solution for your battery system based on your wishes.

We use either standard commercial batteries and rechargeable batteries, to whose manufacturers we have built up good contacts over the years. Or we can tailor the right solution for you to the available installation space in your application and according to your technical requirements.

In order to offer you a cost-effective solution, we apply the current methods of Lean Production. The requirements of ISO 9001 or, at the customer's request, ISO 13485 are also applied.

Our customers include well-known companies from a wide range of industries, e.g. manufacturers of medical technology, mobile measuring devices, garden equipment, wind turbines and E-bikes.

In our opinion, the best solution is always found in close cooperation with our customers, taking their individual wishes into account. With this mindset we have gained over 40 years of good experience and received various awards from our customers.

WOULD YOU LIKE TO GET TO KNOW OUR COMPANY?

Then come and visit us in our new competence centre in Hilchenbach or in Schlangenbad! We look forward to hearing from you!

ARE YOU INTERESTED IN RADIO RELAY SOLUTIONS?

Omnitron has also been providing microwave data networking solutions for over 25 years. If you are interested in such solutions, please follow the link RADIO RELAY link.

CONSULTING

At our competence centre in Hilchenbach with our own training centre and test laboratory, we offer the following services and trainings for our customers:

• Information on new legislation
  We advise our customers on legislation and offer training on dangerous goods handling.
• Supervision / support and implementation of approval procedures
  We advise you on international regulations and approval procedures and implement them for you (IEC, UL, CB report, other regulations and approvals).
• UN transport test (UN 38.1.)
  The UN transport test is urgently required for a Li-Ion battery pack if you want to bring it onto the market. At OMNITRON we carry out this test for you.
• Cell advice
  When selecting the right cell for your battery pack, we advise you on the technical suitability, longevity and long-term availability of the cells.
• Advice on safe packing construction and longer product life cycles
  Cell manufacturers with whom OMNITRON GRIESE cooperates have proven themselves over many years. Through regular exchange and quality controls during factory visits or in our test laboratory, we regularly check the reliability of our suppliers. In addition to the selection of other, safer electronic components, the design of the battery pack also plays an important role. At the customer's request, OMNITRON also develops a test stand which can also be used by the customer to check the battery pack.
• Support in product development
  In general, we already advise you during your product development. Early coordination, for example, can prevent that too little space is planned for the rechargeable battery pack.
• Simulation and tests under specified environmental conditions
  In our test laboratory, we can simulate the current behaviour of your application and test the battery pack accordingly. For example, ambient temperatures to which your rechargeable battery pack will be exposed in the future can be simulated in the climate chamber.
• Electrical and Mechanical Feasibility Analyses
  If requested, we can check your electronic components with regard to risks or your casing data with regard to passing the necessary tests such as the UN Transport Test 38.1.
• Preparation of drawings and 3D data of rechargeable battery packs to support your product development/rapid prototyping
  We are happy to provide you with our drawings to illustrate your Li-Ion rechargeable battery packs. During your product development phase, we create prototypes for your casing and are happy to advise you on the wall thickness of your metal or plastic casing.
• Market information and trends
  Regular updates on market developments and individual suggestions for integrating new technologies into customer-specific systems round off our service package.
• Design consulting / value engineering
  Together with our customers, we carry out value engineering in order to technically and economically optimise your Li-Ion battery pack. For example, the use of long-term UL components for the load board may play a role.