Medical Device Contract Manufacturing: How to Find the Right Fit for My Product?Ariel Pollock Star
Medical Device Contract Manufacturing: How to Find the Right Fit for My Product?
When it comes to medical device contract manufacturing, finding the right fit is crucial to your success. Apart from initially manufacturing your products, they are the ones to support you along the way, even after bringing your product to market.
In this article we look into why it’s important to find the right medical device contract manufacturer, as well as important factors to consider in your selection.
The Importance of Choosing Wisely
Accountability for Device Quality
The OEM is held accountable by authorities for its quality. In the event where a quality issue arises and needs to be addressed, the OEM will require the full support of the medical device manufacturer. This is why choosing a manufacturer with exceptional quality track record and after-sales support is crucial.
Quality Inspections Support
Whenever your product is fully audited for manufacturing by authorities such as the FDA or EMA, the auditors will visit the original medical device manufacturing company. Any issues or inspection observations will need to be addressed for your product to be cleared for the market.
Product Dossier Support
When bringing your medical device to market, you will need to submit the medical device dossier to the authorities of each jurisdiction. The OEM can be asked to provide additional information, amendments, answers to questions or further clarifications. You will be fully dependent on the contract manufacturer to provide the documentation of its manufacturing process. Therefore, it is of utmost importance to verify that the contract manufacturer has a sound policy in place for monitoring and documentation.
What to Look for in a Medical Device Contract Manufacturer
Now you understand that the manufacturer is an integral part of your medical device’s entire lifecycle, rather than just a starting point. Here’s what you need to consider when choosing a medical device contract manufacturer:
The medical device manufacturer has to meet all quality regulations. This includes compliance with all applicable ISO international quality standards, as well as FDA, EMA, and other major bodies regulations.
The manufacturer should have a specialized factory, focusing exclusively in medical devices production. Ensure the know how and proper level of service is suitable for medical device production. This is required throughout the various levels associated with manufacturing, from line operators to top level management.
A medical device contract manufacturer should be able to support production of both small prototypes, as well as large scale production runs. This way you don’t have to change manufacturers throughout different stages of product life cycle .
Medical device contract manufacturing very often requires tailored production techniques relevant to your product. This requires both knowledge and infrastructure to do properly -and can save you a lot of money in equipment expenses.
Quasar is a trustworthy medical device contract manufacturer, specialized in the development, manufacturing and ongoing support of medical devices.
Quasar has more than 30 years of specialized experience in medical devices development & manufacturing, with a worldwide clientele that spans from medium-sized to Fortune 500 companies, such as Medtronic™ and Johnson & Johnson™.
Choosing an effective, specialized, experienced medical device manufacturer can be the enabling factor which plays a critical role in your company’s bottom line. Contact us to discover how Quasar can become your trusted partner.