Six Things to Consider When Choosing a Medical Device Contract Manufacturer

When you’re searching for the right contract manufacturer for your medical devices, it’s extremely important to make sure you’re looking for a number of key attributes that will help to ensure the successful launch of your product. In this post, we will look at six things to look for when you’re considering a medical device contract manufacturer.

1. ISO 13485 certification

ISO 13485 certified manufacturers have demonstrated that they have implemented a comprehensive quality control system. This certification allows you to be confident in the output of your chosen device manufacturer.

2. Supply chain management knowledge

Having extensive knowledge of supply chain management ensures that the manufacturer will be able to source high quality, reliable parts and components for your medical device project.

3. Capabilities and infrastructure

Each medical device program has specific needs and requirements from a manufacturing standpoint.  When selecting a contract manufacturer, make sure that their capabilities align with your product’s needs.  It’s also critical that your contract manufacturer has the infrastructure in place to meet the demands of your current volumes and also room to grow as your program experiences continued success.

4. Effective project management

The path to launching a device into manufacturing can be a long and arduous process. However, that doesn’t mean that it has to be painful. Experience in managing projects effectively means that your project will remain on schedule without compromising the quality of your medical device.

5. Long term product assistance

At Keystone Solutions Group, we strive to give our clients the best possible chance at creating a successful, widely-adopted medical device. To accomplish this, we provide long term assistance in the warehousing, distribution and shipment of your product. Offering Kanban, vendor managed inventory, ongoing customer support and order fulfillment, we work – at every stage – toward giving your device the opportunity that it deserves.

6. Values and cultural alignment

Last but not least, and often understated, when engaging a contract manufacturer it is important to insure that there is an alignment with your company’s values and culture.  Why is this important?  Your contract manufacturing becomes an integral part of your team and in order for you to be successful; everyone needs to operate under the same values and culture.

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