Collaborating on Next-Gen Diagnostic Instrumentation
Keller Technology co-developed a next-generation laboratory diagnostic instrument. Having built the first-generation instrument allowed Keller Technology to integrate improvements into the new design. Value analysis allowed for cost containment and reduction while engineering the new instrument. While unable to share specific project details to protect our customer’s intellectual property, we would like to share some […]
How a Contract Design and Manufacturing Firm Can Make Your Product a Reality
A contract manufacturer (CM) can help bring a promising concept for an industrial product to life. CMs should collaborate closely with core technical personnel to define the parameters of the equipment. A CM design and testing phase includes refining the design and developing a supply chain. Whether your company is a venture capital-funded start-up, or […]
Why Protecting Intellectual Property Is Serious Business
Choose a contract manufacturing partner that will protect your intellectual property. A contract manufacturer (CM) should focus on IT security to project your IP from breaches. The contract manufacturer you select should have procedures in place to restrict entry to its facility. We’ve all heard the horror stories of a company suddenly competing against what […]
5 Things to Consider When Outsourcing the Manufacture of Medical Equipment Assemblies
Medical device manufacturers can benefit from outsourcing high level assemblies. Contract manufacturers (CMs) should hold ISO 9001 and ISO 13485 registrations. The chosen CM should have a well-developed supply chain. For some producers in the medical industry, particularly those manufacturers of large, capital medical equipment, it may be impractical or impossible to outsource the entire […]
Does Your Contract Manufacturer Need to Be ISO 13485 Registered?
ISO 13485 registration is a necessity for medical device manufacturers. Avoid potential liability issues by partnering with a 13485-registered CM. Consider ISO 9001 registration for the manufacture of non-medical devices. There seems to be an emerging debate on the necessity of selecting an ISO 13485-registered company to handle contract manufacturing needs. Let’s begin with the […]
Three Points to Consider When Selecting a Contract Manufacturer for Medical Devices
An ISO 13485 registered contract manufacturer (CM) must regularly demonstrate existing infrastructure to encompass the traceability, risk assessment, and QMS required to support their customer’s regulatory compliance. A CM should have business systems and procedures in place for achieving and maintaining aggressive schedules for the manufacture of your particular medical device. A CM must have […]