Our Quality
Based on the experience and skills established over the last 15 years, we have developed a range of materials that meets and exceeds the regulatory standards of EN13795, EN866-2and ISO 11607-1.
For ensuring to provide the highest level of protection to patients and surgical teams, our team makes the testing undertaken for the full range of products go beyond the required to satisfy the Medical Devices Directive.
The market-leading performance is confirmed by the testing of absorbency, spread, and runoff.
Regulatory Compliance
Our products are CE marked in accordance with the Medical Device Directive 93/42/EEC.
Our Plants are Certified to:
ISO9001, ISO13485 and Directive 93/42/EEC
Our products are certified to:
ISO9001, ISO 13485 and Directive 93/42/EE