OEM SOLUTIONS

All the way to a marketable product from one source.

Turnkey systems or modular services
– We’ll take care of it.

From the initial idea through to our global service concept, we provide custom solutions that meet your requirements. To permit the creation of a new, future-oriented, and marketable medical device, our experts are on hand to guide it through every stage in the process. A product will not move to the next stage until it meets the defined requirements.

Conception

Our cooperation starts with a product idea, which we mold into an optimal product concept, taking into account all the applicable technological and economic considerations with a focus on clinical relevance, serviceability, and regulatory requirements. This is a time of intensive communication between you and our experts. The next stage will commence only once the concept has been finalized and the expected duration of the project has been defined.

Prototyping

Using fast-track manufacture, which involves turning the conceptual drawings into functional models, we are able to achieve fast turnaround times and avoid errors of concept.
The resulting acceleration in time to market provides you a clear competitive advantage. During this stage, we use rapid prototyping to create models that validate in feasibility studies the product concept and the technical design.

Functional Testing

During this stage, the prototypes are put through their paces under real-life conditions. The concept is once again subjected to thorough testing within the intended application. We perform the initial tests under simulated conditions, which frequently offers scope for developing additional product features. This stage concludes with finalization of the requirements specification document that includes a service and registration concept for your product.

Engineering

Your product will be developed and prepared for series production in Denzlingen on the basis of the requirements specification document. Our sophisticated industrial engineering processes and in-house jig construction expertise in the areas of micro- optics, mechanics, and electronics allow us to achieve reproducible quality, exceptional process stability, and compliance with specific certification and regulatory approval requirements. During this stage, we also begin material compatibility and reprocessing tests in our own certified test laboratory. Our main focus here is economic production at the highest quality.

Registration

We make sure that your product meets all the applicable international regulatory requirements to facilitate and accelerate  a smooth market entry. The observance and documentation of defined processes within the scope of a multi-certified quality management system ensure that the required documents – for example for RoHS, REACH, material compatibility, reprocessing, biological evaluation, or IEC reports – are available in a timely manner. This is beneficial for certain regulatory approval and direct registration processes that are specific to products and countries, such as FDA (USA), CE (Europe), ANVISA (Brazil), Health Canada (Canada), CFDA (China) and MHLW (Japan).

Production

Our expertise in bringing new developments to series production as well as our high level of vertical integration permit continuous quality control and short lead times whatever the volume. Our high quality standards are assured by state-of-the-art machinery, efficient organization of the workplace, and regular training. Production is distributed over multiple locations, allowing us to achieve a high level of efficiency and safeguard production for ourselves and our customers should we reach maximum production capacity in Germany.

After Sales Service

Attractive offers for the technical service of your specific products round out our portfolio. Wherever you are in the world, our service centers provide exceptional technical support for your products. Our highly qualified service technicians take care of the necessary steps as required. From traditional repairs through replacements, we work with you to define the most appropriate package for your requirements, prevailing local conditions, and your distribution strategy. Additional services such as consulting, support or training are part of our After Sales Service.

 

 

Technical specifications are subject to change. The information is not legally binding. The contents are only for information about our products. Reprint, in whole or in part, is not permitted. Medical devices are only allowed to be marketed and used in countries where they have been approved for sales by regulatory authorities. For information on the available market access please contact us.