Medical devices don’t just have to perform; they have to prove that they perform. From the materials they use to their safety and efficacy in trials, their every aspect is subject to scrutiny, and for good reason. The cost of failure, in both money and human welfare, can be huge. Material issues include biocompatibility, adhesion of dissimilar materials, and deep understanding of individual material characteristics. Processes must be clean, consistent, and compliant with ISO standards, and records must be available for the FDA approval process. Finally, with all these complex demands, end products must be cost-competitive in order to succeed in today’s challenging markets.
7-SIGMA is committed to the highest manufacturing standards and the requirements of medical device manufacturing. Our advanced material characterization capabilities are unique in the industry. We excel at specialized processes including Teflon® and polymer/metal adhesion, precision coatings, and liquid silicone molding. Our engineers have the experience and technical strength to help address complex design challenges. 7-SIGMA manufacturing processes comply with ISO standards and are designed for maximum quality and consistency. Our production records are clear, accessible, and compatible with regulatory requirements to help simplify the FDA product approval process.
For information on our innovative, high-performance polymer solutions for medical device manufacturing applications see our “white papers” below or contact us.