Quality Assurance
Ensuring the quality of your medical device is our priority. At Medibrane, we help bring your product from concept to commercialization with the highest standards of quality. Our ISO 13485:2016-certified facility rigorously adheres to quality protocols at every stage of the process, from material selection and testing to full-scale production in our ISO 14644 Class 7 and 8 cleanrooms.
Our team works closely with manufacturers to ensure your product consistently meets market needs and patient safety standards, offering expertise in quality management to maintain product integrity throughout the entire production cycle.
Manufacturing
Medibrane offers integrated contract manufacturing solutions for medical device and pharmaceutical industries. As an FDA-registered, ISO 13485:2016-certified company, we provide access to over 10,000 sq. ft. of ISO 7 cleanroom space, specializing in small- to medium-scale projects.
Backed by our extensive expertise in polymer coatings and advanced medical device technologies, Medibrane provides the final development and finishing of your product. Whether independently or in collaboration with your team, we deliver quality-driven manufacturing services, ensuring regulatory compliance and reliable production.
Contract Manufacturing
With a focus on precision and rapid production, Medibrane offers high-quality solutions for medical device manufacturers, guiding you through material selection, product design, and full-scale production.
Operating within ISO 14644 Class 7 and 8 cleanrooms, our capabilities allow us to coat and produce components using a wide range of materials, including specialized polymers. Our expert team combines decades of experience in advanced coating technologies, precision textile production, and custom equipment, ensuring that your medical device is built to support the next generation of healthcare innovations.
Design and Development
At Medibrane, we take a collaborative, multidisciplinary approach to medical device design and development. From initial consultation and prototype development to advanced design, we engage you in every step of the process. Our expert team in polymer engineering, coatings, and manufacturing ensures that your product meets the highest standards of performance and precision.
Key stages of our development process include:
- Assessing clinical and engineering requirements.
- Identifying optimal design structures and concepts.
- Addressing biomedical challenges.
- Refining performance specifications.
- Optimizing product structure and design for medical applications.
