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Medical device contract manufacturing is a service where a company specializes in producing medical devices for other businesses.
This process can include the creation of prototypes, large-scale production, and assembly of a wide range of medical devices.
By outsourcing production to Vantage MedTech, you can focus on core activities like research and development, while we ensure the devices meet all industry standards and regulations.
Medical device contract manufacturing is governed by stringent regulations to ensure safety and effectiveness. In the United States, the Food and Drug Administration (FDA) sets these regulations under the Federal Food, Drug, and Cosmetic Act.
Global manufacturers must adhere to the International Organization for Standardization (ISO), specifically ISO 13485, which sets international standards for quality management systems in the design and manufacture of medical devices.
Contract manufacturers can assist with prototype development for medical devices. We offer comprehensive services that include design assistance, material selection, and the creation of functional prototypes.
This process allows for testing and refinement of medical devices before mass production. Our expertise in engineering and manufacturing ensures prototypes are developed efficiently and adhere to necessary regulatory standards.
The typical timeline for a medical device manufacturing project varies based on the complexity of the device and the project's scope.
However, most devices do generally go through the same series of steps.
Vantage MedTech works closely with clients to establish a detailed project timeline, considering all critical milestones. Our aim is to optimize the manufacturing process for efficiency without compromising on quality.
In medical device manufacturing, materials are selected based on the device's intended use, durability requirements, and compliance with medical standards.
Common materials include: