Is Your ECM Experienced in Building Medical Devices to Industry Standards?
Posted On February 18 2022
Medical device manufacturing has high industry standards. With the importance of each device and the potential impact on humans, these standards are required to be rigorous. When you are looking for an electronic contract manufacturer to partner with for your medical device manufacturing, you need to know that you have selected a partner with the right skills, experience, certifications, and facility to meet the needs of your medical device manufacturing and assembly.
Does Your ECM Have the Right Team?
Electronic contract manufacturers with the proper certifications and industry experience likely have the capabilities to handle your next project. When looking for a partner for medical based electronic projects, you’ll want to find a partner who has the correct certifications. Working with an ECM that is certified in compliance requirements such as ISO 13485 reinforces that the manufacturer is trustworthy. An ECM with experience working on medical device projects will be a valuable asset for you to have. Human error is most likely to occur when a project passes from stage to stage between different shops. Keeping all the stages in one facility will minimize this risk. A turnkey partner – one who will see your project through from design to delivery – is the right choice for medical device projects. When your build can be completed under one roof, you will have one contact throughout the duration of the project to ensure that nothing is missing or lost in communication, and your project manager will have complete oversight as your project progresses through assembly and shipment.
Does Your ECM Have Reverse Engineering Capabilities?
Reverse engineering capabilities are essential to medical device manufacturing. The medical industry tends to use tried and true devices and aren't quick to jump on the "next big thing" in terms of medical devices. New technology often comes with a learning curve. Doctors typically stick with equipment they fully understand and know they can rely on.
Because of this, legacy designs are relied on heavily by medical professionals. However, the design of these devices tends to largely outlive the life cycle of the electronic components inside it. The ability to continue using legacy medical devices will rely on talented ECMs with engineers on-site who can reverse engineer successful legacy devices and streamline the design for better usability and parts procurement.
Having the right engineering team to troubleshoot and understand the build is crucial to building a reliable, high-quality medical device. They can provide valuable information to make every device better and will ensure that the devices are meeting and exceeding the standards set by the governing bodies.
Does Your ECM Have a Vetted Supply Network?
Traceability is extremely important in medical device manufacturing. Manufacturers need a documentation system in place that allows them to track every detail of the medical device build. All parts, components, and materials need to be trackable in the case of a recall. Having an ECM with a vetted supply network and a counterfeit parts mitigation system in place demonstrates that your ECM understands the importance of traceability in medical device manufacturing. Before beginning your partnership, confirm that your ECM has a documentation system in place that will track all electronic components used in the devices. In addition, this documentation system should include manufacturing steps, testing procedures, and the technicians responsible for the build. In case of a recall, all this information can be readily available, and you will know that all parts and components are high-quality and meet the required specifications for medical devices.
PFMEA is Important to Medical Device Manufacturing
Process failure mode and effects analysis (PFMEA) is an important part of medical device electronic manufacturing. This will help identify potential failures based on experience with similar processes and the consequences of those failures. Each failure mode and effect will be recorded to ensure reliability in the manufacturing process. Using this will help the engineering team adjust the design to prevent problems and fulfill the legal requirements of product liability. In medical device manufacturing, this is even more important.
Simply meeting the minimum requirements is not enough when it comes to medical device manufacturing. It is important to look at your ECM as a partner and determine if they have the right experience, capabilities, and certifications to handle the project. Levison Enterprises is well versed in medical device manufacturing, and we can help create, design, or streamline your medical device while upholding the reputation you’ve built in the healthcare industry. When you partner with a certified ISO 13485 company, you ensure the quality of your products will be upheld. If you’re ready to talk about the details of your next medical device project, contact us today.
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