add'n solutions GmbH & Co.KGMedical device labeling

Global regulatory agencies such as the US FDA and the European Commission have issued strict guidelines for the labeling and registration of medical devices. Labeling is therefore not just the application of a label to the outer packaging, but a critical process for placing medical devices on the market. In addition to the design and printing, we also offer the physical application of FDA and MDR-compliant labels. A wide variety of product information such as article number, description, bar and 2D codes as well as the required symbols (e.g. according to DIN EN ISO 15223-1) can be applied to the labels. We provide comprehensive documentation for both the validation of our devices and processes and the verification of the labeling we have applied. We have specific software that enables us to generate a wide variety of labels that also meet GS1 and HIBCC-compliant code requirements. We either use your label design or, in close consultation with you, create individual label templates in various label sizes. Using a verifier specially developed for printed labels, we can read the content of the barcodes and create corresponding verification protocols.

In addition to traditional adhesive labeling, we also have a device for direct printing of the labeling on PE bags, which is particularly useful for larger quantities. Here, too, we can adopt the specifications from different file formats according to your specifications or develop the content and design of the label together with you.

add'n solutions GmbH & Co.KGAll showrooms

Details

Passivation of workpieces

  add'n solutions has decided to passivate with citric acid due to the better results and the safe handling. This process takes place in our fully automatic, validated cleaning and passiva...

Details

Cleaning of work pieces

add'n solutions has the option of getting workpieces clean with various methods, processes and cleaners. There are two different pre-cleaning methods available. Depending on the type of contaminat...

Details

Packaging of surgical instruments

Finding the right packaging for the multitude of surgical instruments, but also for products from other industries, can pose major challenges for a company. We support you in bringing your products, w...

Details

Laser marking

With modern equipment, we can label your products precisely and in a validated manner. To implement the UDI guideline, we have developed a process that guarantees you labeling in accordance with all F...

Details

Medical device labeling

Global regulatory agencies such as the US FDA and the European Commission have issued strict guidelines for the labeling and registration of medical devices. Labeling is therefore not just the applica...

Details

UDI code verification according to ISO15415 and ISO / IEC TR 29158

Verification means providing evidence that a fact is true. Using the UDI code verification in accordance with ISO15415 and ISO / IEC TR 29158, we ensure that the barcodes that we label and print compl...

> Diese Kategorien könnten Sie interessieren

Label printer

Label printer

Labeling for medical devices

Laboratory labeler