Bioinicia gets ISO 13485 for manufacturing medical devices of electrospun materials

Bioinicia obtains ISO certification for its industrial manufacturing plant for electrospun nanofibers

Paterna, Spain – January 17th, 2018: Spain-based Bioinicia SL announced the ISO certification for the production of nanofiber-based medical devices.

Bioinicia is proud to announce its recent accomplishment in achieving ISO 9001:2015 and ISO 13485:2016 certification for its industrial-scale nanofiber production facility, enabling the manufacturing of medical devices for clinical use.

Bioinicia electrospinning facilities

Bioinicia is an engineering company dedicated to the development and manufacturing of nano- and microstructured materials by electro-hydro dynamic processes (i.e. electrospinning and electrospraying) for its clients, and to providing premium quality equipment for laboratory to industrial-scale processing.

This latest accomplishment demonstrates Bioinicia’s dedication to providing the highest level of manufacturing service for its clients. Using its expertise in the electrospinning process from laboratory research to industrial manufacture, as well as in the areas of biocompatible materials and medical device development, Bioinicia can assist its clients in developing novel products from concept to market.

In recent years, electrospun fibers have been shown to have great potential in a range of biomedical applications, owing in many cases to the similarities in physical structure between electrospun materials and

the extra-cellular matrix (ECM) within the tissues of our bodies. Adding to that the flexibility in terms of the range of materials that can be processed and the ability to control the structural morphology of the material, electrospun fibers are starting to find their way into the clinic in products such as scaffolds for regenerative medicine, bio-resorbable implants and wound dressings.

About Bioinicia

Bioinicia S.L. is a privately held materials science and engineering company dedicated to the development, industrial scale-up and manufacturing of nano- and microstructured materials by electro-hydro dynamic processes (i.e. electrospinning and electrospraying) for their clients, and providing premium quality equipment for laboratory to industrial-scale processing.

Bioinicia acts as a partner for product development, electrospinning-electrospraying technology and industrial manufacturing.

For additional information, please visit www.bioinicia.com.

 

 

 

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