What are FDA's Requirements for Medical Device Shaping Services?

Plastic injection molding of medical devices is a critical process, and the risk of failure is very high. Therefore, some factors must be considered in the design, planning, and manufacturing process. What are the FDA's requirements for medical device injection molding services?

1. FDA regulations

FDA regulations on cleanliness and sterility are the primary considerations for medical components, both in the component itself and in the manufacturing process. Ensure that the selected materials meet these standards and that the manufacturing partners can pass audits or other regulatory requirements to obtain medical grade approval.

2. ISO certification and compliance

ISO regulations govern the processes and outputs of many industries including the medical industry. At a minimum, facilities that produce medical components must comply with the ISO 13485:2003 standard and further comply with Class I, II or III requirements, depending on the product being manufactured.

In addition to other application or product-specific standards, biocompatibility standards, such as ISO 10993, may also be required. Ensure that manufacturing partners understand the standards related to the application and that the clean room injection molding factory can achieve and maintain compliance through audits.

3. Material characteristics

The materials selected by medical molding companies for medical components and devices must have specific physical properties to be suitable for these applications.

4. Can be disinfected

This is the minimum requirement for any medical component, whether it is a device housing in a facility or a part of a device that directly interacts with the human body. The material must be resistant to contamination and be able to be disinfected to prevent harm to the people with whom it interacts.

5. Suitable for extreme environments

Biological implants must be able to cope with the harsh environment of the human body, including reliability and durability when exposed to heat, liquid, corrosiveness, vibration, and other movements. Fortunately, many plastics used in injection moulding meet these requirements.

6. Durability

Fragile materials are not practical in the medical industry because they are dangerous and inconvenient. Ensure that the selected material has the anti-fragmentation and anti-breakage capabilities required by the medical field.

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