Providers & Products

We have manufacturers, suppliers and service providers from the area Custom-made / customer-specific medical devices

1 - 25 by 25 results

Rudolf Storz GmbH
Healthcare & Medical assemblies
PAYER International Technologies GmbH
Healthcare & Medical Fluidics
PAYER International Technologies GmbH
Manufacturing of implants
JakuTec Medizintechnik GmbH & Co. KG
CNC Production
Formo GmbH
Bone plates and screws
HIPP medical AG
manufacture of instruments
JakuTec Medizintechnik GmbH & Co. KG

1 - 13 by 13 results

Custom-made / customer-specific medical devices

Custom-made / customer-specific medical devices

Custom made medical devices are devices that are not standard products. They are ordered under a written prescription from an authorized professional. For example, a Medical Doctor may request a specific device for a patient. The medical practitioner will describe the specific requirements, such as the design, anatomy, and materials. The manufacturer of the device must follow these guidelines, which can be a bit tricky for a small company. But, if the device is of a high enough quality and cost, it could make the difference between a high-quality product and a low-cost device.

The manufacturing of a custom-made medical device can be challenging, but the benefits of working with a trusted manufacturer are significant. While AM can produce a variety of shapes, materials, and features, the process is complex and requires expertise. In order to be effective, the manufacturer should take care to understand clinical data. Segmenting relevant parts from a DICOM file is an important part of the AM process. The data must be converted into the necessary CAD or stereolithography format. The clinicians and engineers will work together on the design and customization effort, but there are common pitfalls to avoid.

During the design process, a manufacturer must ensure that the design and construct of a custom medical device are compliant with regulatory requirements. This means eliminating risks as much as possible, ensuring adequate protection against risks, and letting users know about residual risk. It's important to consider the chemical, physical, and biological properties of a medical device to avoid infection or microbial contamination. The manufacturer should also consider radiation and other environmental conditions to ensure that the device is safe to use.

The manufacturing process for custom medical devices is more complex than for mass-produced products, so manufacturers must get a manufacturer's, importer's, or wholesaler's license before selling to consumers. While they are generally more expensive than mass-produced items, the FDA and NMPA do recognize their uniqueness. However, custom-made medical devices still have to go through standard market clearance and approval processes to ensure they're safe and effective.

In addition to having a unique design, a custom medical device must also be made in accordance with the written directions of a health care professional (HCP). The manufacturer must provide a declaration that contains data that allows the device to be identified and be used by the patient. It must also state that the device is intended solely for the patient. It should include the name of the patient, the name of the medical practitioner who issued the prescription, and the name of the clinic.

A custom-made medical device is produced on a written prescription. Its manufacture is unique to the patient's specifications. A custom-made device is typically more costly than mass-produced products, and the FDA may refuse to accept it if the manufacturer does not have the necessary certification. A physician should also carefully evaluate the custom-made device's performance after the trial period is over. It should also be durable, fit the patient, and be suitable for use.

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