Means Engineering, Inc.

Product development engineering in medical, industrial, semiconductor equipment & military with a standard of excellence in form, function and design.

(760) 931-9452 | info@meanseng.com
5927 Geiger Court, Carlsbad, CA 92008-7305

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Choosing an Electronic Contract Manufacturer for Medical Device Creation

July 31, 2020 By cscheafer

Creating devices for the medical industry requires extensive experience and knowledge of industry requirements. Medical devices are highly regulated for both quality and reliability. This is important, as many people rely on the safety and efficiency of medical devices. Perhaps more than any other industry, OEMs planning to produce products for the medical industry should partner with an experienced electronic contract manufacturer.

In addition to understanding how to comply with government regulations, an experienced ECM should meet the following requirements. This can help ensure a successful and mutually beneficial partnership.

Experienced Technical and Managerial Team

The more experienced the electronic contract manufacturer is, the more likely they can help when problems arise. ECMs with experience producing a wide range of devices can often locate problems and suggest viable solutions based on findings from previous projects. In addition to solving problems that arise during production, experienced ECMs can assist with design-for-manufacture review, saving OEMs a considerable amount of time and money on assembly.

Well Maintained Equipment

It’s not enough for an ECM to have quality equipment. They need to properly maintain it to ensure continuous and reliable operation. Calibration of machines and tools should take place at regular intervals.

Proper maintenance not only helps ensure on-time delivery of high quality products, it also allows the ECM to achieve the right tolerance. This is especially important as the medical device industry has stringent tolerance requirements.

Ability to Adjust to Meet Customer Changes

Needs and requirements can change. This is why it’s so important that OEMs select an agile, flexible, and highly responsive ECM to work with.

ISO 13485 Quality Management System

The international standard for a quality management system for the medical device industry, ISO 13485 is designed to be used throughout the entire lifecycle of the medical device. Using ISO 13485, organizations can develop a quality management system that ensures the quality of finished products and the effectiveness of manufacturing processes.

Means Engineering offers electronic manufacturing services for the medical device industry. Our extensive experience and quality management system allows our team to manage risk effectively and bring safe and effective products to market.

Filed Under: About Us Tagged With: carlsbad contract manufacturer, carlsbad contract manufacturing, CM, contract manufacturer, contract manufacturing, ISO 13485, medical devices, medical industry, southern california contract manufacturer

ABOUT US

MEI features depth of experience in medical, industrial, semiconductor equipment and military products. All product development efforts start with a unique set of requirements, yet we deliver results that share a common standard of excellence in form, function and design.

Our turn-key capabilities provide smart, simple solutions to cumbersome outsourcing issues, and provide our clients with an intelligent route from concept to market.

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