MediSil has a knowledgeable staff with over 30 years of experience in the most critical applications for implantable silicone products. We have the facilities, equipment, proven technology, FDA relationships, and direct experience to meet any medical device requirement. Our biocompatibility testing database meets most requirements for ISO 10993. We also have experience in complying with Canadian, British, Australian, European, and Asian medical device regulations. Because we can manufacture from basic silicone polymer chemistry, our service is truly unique in today’s market. MediSil can efficiently manage every aspect from product design, to regulatory submissions for medical devices.
Our manufacturing is governed by the principles of ISO 13485:2003 and each batch is quality tested from raw materials to finished goods. All materials are tested according to ASTM standards and all instruments are calibrated to NIST traceable standards. We provide Certificates of Analysis for every lot shipped.
At MediSil, you can be assured that your product design and/or medical device will be held in strict confidence. We require a Confidentiality Agreement to protect all parties’ critical proprietary interests.
Medisil customers can be assured the they will be provided with a wide array of silicone products at competitive prices. We have full time dedicated sales representation in Europe and the US and serve customers throughout the world. MediSil Corporation is committed to supplying our customers with quality products that meet or exceed their expectations.