Biosil’s Quality Assurance Department is responsible for establishing and maintaining a quality management system in accordance with the international medical device standard ISO 13485:2003 to ensure all activities conducted within Biosil comply with all applicable European and International quality standards.
All implantable grade raw silicone materials used by Biosil are supplied by an ISO 9001 certified source and are manufactured following GMP guidelines defined in 21 CFR Part 820 and are designed and tested to meet ISO 10993 biocompatibility requirements.
Biosil’s manufacturing processes are subjected to strict manufacturing controls, with all products designed and tested to comply with applicable European and International standards.
The products are manufactured in environmentally controlled ISO 14644-1 Class 7 (class J / 10,000) compliant clean rooms with implants tested to comply with the physical and mechanical testing requirements of the implant standards BS EN 12180 and BS EN ISO 14630. In compliance with these standards, all implants are subjected to extensive shell integrity testing including elongation, tensile set, tear resistance and seal strength and mechanical testing for fatigue, impact and abrasion resistance, gel cohesion and diffusion, and valve competence (where applicable).