Best Practices in Quality Systems for Medical Devices

Quality is extremely important when it comes to medical device manufacturing. However, quality can be overlooked when developers are designing a new device. A quality program should be considered and implemented at the very start of a device’s design process. Medical device manufacturers also need to know the requirements that outline the criteria for successful quality programs; the ISO standards, and the U.S. Code of Federal Regulations (CFR) regulations. This white paper discusses the manufacturing requirements of CFR Title 21, Part 820.