At Rotem Medical Imaging, we offer a comprehensive range of manufacturing services performed in strict adherence with GMP, FDA, and Israeli MOH regulations. Our OEM and CMO services include:
We provide comprehensive technical and regulatory support to our clients. Our team is dedicated to assisting you throughout the entire product development and manufacturing process, from concept to commercialization.
Our chemicals department offers a one-stop-shop solution for all your chemical needs. We specialize in Full Fill and Finish services, providing precise formulation filling and comprehensive chemical solutions.
Our state-of-the-art equipment, including autoclaves, sterilization ovens, glove boxes, and filling/dispensing machines, is validated to stringent GMP standards and operates within Class C/D rooms. This ensures a controlled and efficient manufacturing environment.
Our Class C clean rooms are staffed by highly skilled technicians who possess the expertise to manufacture products that meet the highest industry standards. Our commitment to quality assurance is backed by Q7 cGMP, ISO 9001, and ISO 13485 certifications, ensuring that our products consistently exceed expectations.
Our expertise in plastic assembly allows us to create tailored solutions that perfectly align with specific requirements of our customers. We work closely with our customers to understand the vision and develop custom assemblies that meet the exact specifications.
Through our partnerships with world-leading suppliers, we offer a holistic approach to manufacturing. From characterization to market entry, we provide comprehensive support to ensure a smooth and successful journey.
Our GMP-controlled packaging processes are carried out by experienced staff who adhere to the highest quality standards. We offer a variety of packaging options and ensure proper labelling and storage conditions.
We provide seamless shipping and distribution services worldwide. With access to front-line warehouses in Europe and the USA, we guarantee fast and efficient delivery.