Process Development & Validation
Our Process Engineering and Validation services help biomedical innovators establish manufacturing processes for their products that are optimized for reliability, compliance, and scalability. We help you make informed decisions about custom tooling and capital equipment. We provide the expertise to design and validate manufacturing processes. Ultimately, we accelerate your time-to-market by ensuring operational excellence.
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Tooling & Capital Equipment
Innovative biomedical products often require custom tooling or new capital equipment. We help medical device companies make informed decisions about the processes they need to create and the partners they chose to work with. We ensure that their manufacturing processes are optimized for reliability and compliance but also built for scale and future product innovation. We have over 45 years of experience selecting, installing, validating, scaling, and maintaining tooling and equipment. We’re ready to help you achieve operational excellence and accelerate your time-to-market.
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Process Engineering
Our process engineering team designs, optimizes, and maintains production processes to ensure overall equipment effectiveness (OEE) and compliance with regulatory requirements. Whether we are working with a new and novel product or an established product, we provide our partners with supply chain resilience, quality and reliability, efficiency, and cost competitiveness. As a strategic manufacturing partner, we know how important our role is in your feedback loop between engineering, manufacturing, and new product development.
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Manufacturing Transfer (IQ, OQ, PQ)
We provide comprehensive manufacturing transfer support with programs that encompass Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). These programs ensure a seamless transition of your products into their commercial manufacturing environment. We have a long track record of success establishing manufacturing operations that are robust, reliable, and scalable.
Please feel out the form below and someone from our team will contact you shortly.
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