Packaging
- Packaging of single-use products:
- Packaging in heat sealed tubular film,
- Packaging in heat sealed bags,
- Single or double packaging,
- Cardboard outer packaging,
- Labelling: standardised label,
- Packaging in blister packs:
- Thermoformed shell: PETG,
- Tyveck® or Aluminium cover (biodegradable products),
- Simple or double shell,
- Labelling.
CE marking accompaniment
In cooperation a partner located in Besançon and specialising
in biomedical products, we are able to offer you the possibility of obtaining
the CE marking of your product, in your name as a manufacturer with the
notified organisations of your choice (example in France, the G-MED).
Possibly your partner may suggest that it be designated temporarily as
the manufacturer, until your structure is certified ISO 13485 and it
may enter into a exclusive licence agreement with you.
Sterilisation
At the customer's request and after packaging the product in the conditions
required, Statice Santé is able to deliver sterile products to
its customers, ready to be placed on the market. The customer is responsible
for the validation of the sterilisation process. The release may be made
under the responsibility of the customer or Statice Santé.
Archiving
Statice Santé undertakes to archive the documents and records
relating to the product for at least its lifespan.
