OEM Solution

Gimmi offers to supply your company with custom-made medical devices or small batches of medical devices that you request. Gimmi has access to more than 100 specialised craftsmen and producers who deliver the highest quality – Made in Germany – to your company.

 

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Gimmi can offer two different models:

Model A – OEM (Original Equipment Manufacturer):

Gimmi produces the finished product for your company. Your company receives the technical documentation from Gimmi in accordance with the relevant regulatory requirements.

Model B – Distributed by:

Gimmi is the market authorization holder of your desired product and your company can sell these products with “distributed by ‘your company name’”. This means that Gimmi takes full responsibility for the product and assists with registration.

 

If your desired product is not listed, you can still contact us.
Within a very short time we will find a producer who can deliver your desired product in highest quality – Made in Germany.


Our Passion:

Gimmi has been offering this model for 30 years and has large and well-known customers in various countries, such as USA, China,  Japan
and also in some European countries.


Our 7 Step Development Guarantee

Ideation / request

During the ideation and request phase, you and Gimmi discuss the initial concept or idea that needs to be explored in detail.

Feasibility

During the feasibility phase Gimmi along with its partners assess, if the requested product can be realized according to your specifications.

Regulatory Assessment

During the regulatory assessment phase Gimmi utilizes its extensive staff of regulatory personnel to evaluate the global regulatory needs in cooperation with you.

Risk Analysis

The risk analysis phase is used to accurately reflect and document the product risk for each of the parameters of the product to minimize any external potential risk.

Prototyping

Gimmi utilizes a three stage prototyping process to insure that the user needs specification are achieved in the design output specifications.

Bench Testing Requirements

Bench testing is an essential element to ensure that your needs and specifications are met as defined in the design input and output specifications. The bench testing is established to accurately assess whether the design meets your requirements.

Customer approval / Manufacturing

After receiving your approval we will immediately start the manufacturing of the requested products in accordance with the ISO 13485.


Certification

Gimmi has implemented a full quality management system and is certified according to ISO 13485. In addition, Gimmi markets its products under its own name. Accordingly, Gimmi can assist with registration and technical documentation.

EN ISO 13485:2016 (381 downloads)

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Robin Fox

OEM Manager

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