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Special Considerations When Evaluating Medical Device Contract Manufacturing Companies

For companies producing their first medical device or for established companies in the medical device industry, outsourcing specific aspects of production to a medical device contract manufacturing service is now an essential part of the process.

By outsourcing to a contract manufacturing company, the OEM relies on the manufacturing company for design expertise, the ability to complete the manufacturing process within a fixed cost amount as well as the option to scale up production to meet demand.

Choosing the right medical device contract manufacturing service starts with evaluating the possible companies. Taking the time to look not just at the bottom line but also to consider all aspects of what they bring to the table and how that benefits your business is critical in this highly competitive field.

Past Projects in the Medical Device Field

While every medical device contract manufacturing company has first customers, it is a definite advantage to choose a service that has experience and practical expertise in the design through the production of medical devices.

With ISO 13485 and FDA registration a must, these companies have both the state-of-the-art equipment as well as the highly trained workforce to be able to manufacture devices to exacting tolerances, specifications, and industry standards and requirements.

Compliance Issues

Take the time to review the contract manufacturing company for any issues with recalls or compliance problems in past projects. The top companies do not have these issues on their record, and they focus on quality control, efficient production and exacting standards in all of the parts and components they manufacturer and assemble.

Ability to Work to Your Requirements

The ability to offer the services and manufacturing tasks required, as well as the ability to provide scalable production is also a factor to consider. Choosing a company that has the ability to work to the volume anticipated for the device means the same contract manufacturer can work with your company throughout production.

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