With headquarters located in the Isle of Man, British Isles; Biosil Ltd was incorporated in 1990 with its first production facility established in Ashby-de-la-Zouch Leicestershire to provide for a growing need for a European based medical devices company dedicated to providing silicone elastomer implantable products for the healthcare market. During the intervening period, Biosil has focused on sustainable growth and development at a consistent pace whilst at the same time responding to and meeting the increasing global demand for its products, with a second facility having been established in 1995 in Cumbernauld, Scotland, to expand upon the specialist expertise gained in this field of design and manufacture.

In particular, Biosil has continued a process of positive advancement based on quality, attracting an international reputation for the manufacture of high precision, high technology medical silicone products.

Biosil’s commitment to providing the highest quality long and short-term implantable silicone implants, as well as a wide variety of non-implantable medical devices and components, is demonstrated by ongoing research and development with investment in the most modern manufacturing processes supported with the most demanding of quality management systems.

Biosil’s technology encompasses the manufacturing processes of Dipping, Injection Moulding, Press Moulding, Extrusion, Calendering and Custom Fabrication of any type of silicone material, in registered and fully certified facilities throughout the UK.

Each of Biosil’s facilities engender Biosil’s philosophy of aiming to improve every aspect of its service where possible and are equipped with environmentally controlled ISO class 7 (class J / 10,000) compliant clean rooms, in accordance with ISO 14644-1. With a determination to comply with the highest prevailing quality and international regulatory standards, Biosil operates under a Quality Management System in accordance with ISO, EN and FDA GMP requirements and manufactures a wide range of CE marked products.

All implantable grade raw silicone materials used in the manufacture of Biosil products are supplied from an ISO 9001 source and are designed and tested to meet ISO 10993 biocompatibility requirements. Each batch of material is 100% verified in accordance with GMP guidelines defined in 21 CFR part 820, prior to its use in production. Biosil manufactures all of the silicone components that are required in the make-up of its complete products and is proud that this self-sufficiency ensures a swift and reliable service is provided to its customers. Finally and perhaps most importantly, Biosil’s commitment to excellence is supported and maintained by the dedication of our personnel to deliver a level of service that is unsurpassed.

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