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Levison Enterprises Receives ISO 13485 Certification

Posted On October 17 2022

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.

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What is ISO 13485? 

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. 

ISO 13485 certification is not a requirement, but many organizations benefit from implementing the standards without going the extra mile to get certified. 

If a contractor has ISO 13485 certification, they also have ISO 9001 certification. ISO 13485 adds critical requirements around medical devices, documentation, and overall safety. An ISO 13485 certified contract manufacturer has been proven to provide the experience needed to navigate both the ISO 9001 and ISO 13485 standards on quality management successfully, and in turn can provide trusted and reliable ECM services for their medical device OEMs. 

Do you know how your contract manufacturer handles product quality systems? 

Don’t be afraid to ask. Your due diligence in finding the right manufacturing partner can directly affect your product’s success. Some contract manufacturers for electronic medical devices still rely on an outdated, unresponsive quality system consisting of paper documentation and spreadsheets. This can be a highly inefficient and inaccessible process. It also creates a risk that an OEM can be held liable should a product malfunction or fail while operating. 

Levison Enterprises offers more than electronic assembly. We also offer electronic design, custom prototype, PCBA manufacture and PCB assembly

Fortunately, the medical device and equipment industries have joined forces to define set standards under ISO 13485 for quality management systems (QMS) and they audit the reliability of manufacturing processes to ensure high quality in medical devices. These standards provide quality assurance at every step of the build from design to fulfillment. 

When a contract manufacturer implements a QMS, this means it has documented processes, procedures, and responsibilities in place to achieve quality objectives and policies. All the activities and processes are coordinated to meet customer and regulatory requirements, as well as continually improve effectiveness and efficiency overall. 

Although ISO doesn’t require a contract manufacturer to earn 13485 or 9001 certifications, some jurisdictions may require working with ECMs that hold ISO 13485 certification before a medical device can be released on the market. In short, achieving certification demonstrates to both regulators and customers that the contract manufacturer has implemented and maintained a QMS in accordance with the requirements of the standard, significantly improving your chances of passing qualification quickly-and in this industry, time is money. 

Levison Enterprises is Now ISO 13485 Certified 

Typically, companies who receive ISO 13485 certification are larger Original Equipment Manufacturers (OEMs). It’s rare to see an Electronic Contract Manufacturer (ECM) like Levison Enterprises seek this certification out. By doing so, we have positioned ourselves to be an incredible resource and partner. As a turnkey, domestic ECM who holds ISO 13485, we have the ability to provide design services, streamline your device functionality and layout, and guarantee a successful medical device on the front end.

Levison Enterprises is the nimble domestic all-in-one turnkey electronic contract manufacturer you’ve been looking for. Partnering with a turnkey medical device contract manufacturing service is one of the best ways to stay competitive in the medical device field. A turnkey contract manufacturer is designed to meet every project need and anticipate future needs to stay ahead of the curve. From design assistance to prototyping, troubleshooting, testing, and manufacturing, the necessary engineers, project experts, and equipment are all available in one facility. 

“I am proud of our organization’s accomplishment in becoming ISO 13485. Through our commitment to continual improvement, we are better positioning ourselves in our current partnerships and are very excited to see what opportunities our future holds.”

David Levison, President

Start Your Quote!

If you’re looking for an ISO 13485 certified contract manufacturer, consider Levison Enterprises. We pride ourselves on our attention to detail to ensure each project is built to the highest quality standards. Contact us today to learn more about our medical device manufacturing capabilities, or to get a quote on your next project.