|With headquarters located in the Scotland, 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.
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.
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.
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
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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