Have confidence in our quality assured production
The Electrospinning Company has achieved ISO 13485 medical device quality system approval, which allows us to manufacture scaffolds suitable for human implantation in our cleanroom.
Based on ISO 9001’s process approach to quality management, ISO 13485 focuses on what we, as a manufacturer, do to deliver safe and effective medical devices.
We recognise that Regulatory authorities in most major markets require, or strongly prefer, that manufacturers marketing medical products have a third-party audited and certified quality management system in place. Our ISO 13485 compliant system ensures that our clients feel total confidence when using our products.
We provide expertise in biomaterials, scaffold design, product development, regulatory support and manufacture.
We offer a flexible service to help translate electrospun innovations to the clinic and are currently working with both universities and medical device companies.
To download our ISO 13485 Certificate click on the download button below