The outsourcing of medical device assembly is increasingly becoming common. As OEMs try to gain an advantage over their competition, they turn to other companies, frequently CMOs, to handle the actual assembly of their products. Medical devices represent a special case. They demand the expertise of specialized employees. They also require space dedicated to the assembly of specific devices – ones meeting the standards established in FDA guidelines.
Medical Device Classification
Medical devices fall into three classes under FDA regulations. The perceived risk defines placement. In assembling the different classes of medical devices, companies must adhere to specific procedures. The purpose is to ensure the medical devices are free from any contaminants that could cause harm to the patient and employee.
Division of the medical devices is accordingly:
Class I: This type of medical device involves the least amount of risk to all involved parties. Items include
- Elastic bandages
- Enema kits
- Examination gloves
- Handheld dental instruments
- Tongue depressors
This group requires less protection and precautions than the other classes
Class II: This group presents a higher risk. Many medical devices fall into this category including:
- Acupuncture needles
- Infusion pump
- Powered wheelchairs
- Pregnancy kits
- Surgical needles
- X-ray machines
Class III: This group comprises the highest level risk. As a result, they have the strictest guidelines for medical device assembly. The list contains such devices as:
- Heart valves
- Implanted cerebral simulators
- Implanted pacemakers
In the cases of both Class II and Class III, the facility will require a cleanroom. This will guarantee proper control and the highest level of quality.
Medical Device Assembly
For those who want to become involved in the medical device industry, it is possible to consider various industrial opportunities. While original manufactories continue to produce items, they still outsource them to reduce costs and remain competitive. COMs and other companies are there to provide medical device assembly.
