FDA Registered Manufacturer
With our certifications coupled with FDA registration and turnkey electronic manufacturing services, Levison Enterprises can handle your next medical device from concept and design to manufacturing and assembly all under one roof in our state-of-the-art manufacturing facility.
Levison is proud to be an FDA registered facility to produce and manufacture medical and surgical devices. Working on FDA-approved devices requires an FDA registration from the manufacturing facility. This means that Levison has demonstrated their engineering and design capabilities for medical device manufacturing and our quality control processes meet or exceed the standards set by the FDA.
FDA Registered Manufacturer: Medical Devices
The FDA (Food and Drug Administration) is the federal organization that regulates and inspects products related to health and safety. The responsibility of the FDA is to ensure the safety, efficacy, and security of the products they regulate. This regulation protects the health and safety of the people who use these products, that the product is effective for the intended purpose, that they haven’t been tampered with, and that the benefits of use outweigh any risk. Some of the products that are inspected by the FDA include medical and surgical devices, medication, cosmetics, and food and beverage. There are several levels, and the highest level (III) requires approval from the government. FDA registration legally allows a company to sell the products manufactured in the United States. FDA registration guarantees a high-quality level, which is critical for devices that can impact health and safety.
It is important to note that the FDA registers processes, not companies. FDA registration does not mean that the facility has registered every product they produce. It does mean, however, that you are working with a company that has the quality assurance practices to pass an FDA inspection or audit.
As a medical device electronic contract manufacturer, Levison Enterprises is committed to delivering outstanding, cost-effective solutions to our customers. We are proud to announce that we are now ISO 13485 certified.
ISO 13485 is the quality management system (QMS) standard for the medical device industry. It outlines specific requirements for implementing a QMS at any facility involved in the design, production, installation, or servicing of medical devices.
Medical device companies looking for a PCB design and assembly partner have many pressing factors to consider, all leading to the end user’s safety and risk thereof. Working with an ISO 13485 certified manufacturer gives OEMs more assurance that their medical devices will pass the rigorous quality and safety requirements specified in standards and regulations.
FDA Registered vs. FDA Approved
Class I and II medical devices are licensed to be produced by an FDA registered facility. For a device to be FDA approved, a company must become FDA registered and the production and quality control processes have been inspected by the FDA. The FDA does not “approve” manufacturers but allows FDA registered facilities to produce FDA approved devices. The manufacturer itself cannot claim the device is “FDA Approved”, and a facility that does so is cause for suspicion. This registration is required annually. An FDA registered facility is required to list the products and devices that are manufactured at that facility and the processes and quality assurances related to those devices.
The Advantages of Using an FDA Registered Facility
Using an FDA registered facility does not mean that every product manufactured in the facility has been registered with the government. It does mean that when you work with an FDA registered facility, you are working with a company that has the quality assurance processes and practices in place to successfully pass an FDA inspection or audit. All the processes exceed the baseline quality standards. An FDA registered facility will source the highest-quality materials available for medical devices from vetted suppliers.
Quality assurance tests are available for all industry products, not simply medical devices. An FDA registered medical device manufacturer will have superior quality control, high-volume production capabilities, excellent customer service, and efficient delivery. Using a facility that is not FDA registered rather than an FDA registered facility is very risky. At best, the product or device may be ineffective. At worst, it means that there is no protection for those who use the device should a client have a harmful experience.
Receiving the annual renewal for Levison Enterprises to be an FDA-registered facility means that Levison’s processes and capabilities are approved to bring FDA’s highly regulated devices to market. When you choose Levison, you know you are working with a facility that has the highest quality assurance practices. With our certifications coupled with FDA registration and turnkey electronic manufacturing services, we can handle your next electronic assembly from idea to design to manufacturing and assembly all under one roof in our state-of-the-art manufacturing facility.