Medical device assembly requires a company to adhere closely to strict and very exacting specifications. The demands made upon those companies who fulfill this role are stringent. Regulations provide close and very tight parameters for all work performed for assembling medical devices. This includes everything from the glue chosen to join components to the error-proofing and traceability methods employed throughout the entire assembly process.
Requirements
The assembly of medical devices requires companies do not veer from the requirements of the company and the specifications provided for them by the United States Food and Drug Administration (FDA).This three-tiered classification system provides details on the entire manufacturing process of medical devices, including assembly.
Concerning medical device assembly, companies must be completely aware of the following:
- Tight tolerances
- Impressive attention to detail
- A clean-room which satisfies the need for a sterile environment
- FDA validated automation technology to reduce human contact with the medical devices
- Use of proper materials when joining components e.g. pins, screws, etc. for metal to metal; biocompatible and fast curing adhesives for the joining of other materials e.g. metal to plastic or plastic to plastic
- Calibration equipment
- Error-proofing and traceability methods to certify the quality and integrity of the medical devices
The intensity of the specifications for control of the assembly of medical devices increases with each classification with Class III demanding the most stringent requirements.
Medical Device Assembly
Original manufacturers are the driving force behind producing an original medical instrument or continuing the manufacturing of various surgical devices. However, they are no longer the sole producer. Today, these companies rely on the experience and expertise of other companies – including those third party firms they hire to handle medical device assembly. By working together, the original company and its third party contractors ensure the product passes all regulatory and functionality tests and is ready for market swiftly and within budget.
