Medical Device Contract Manufacturing: How to Find the Right CM for My Product?
When it comes to medical device contract manufacturing, finding the right fit is crucial to your success. In addition to manufacturing our product, medical device contract manufacturers provide ongoing support throughout the product life cycle, including Quality, Regulatory and compliance.
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 OEM is held accountable by healthcare authorities for its quality. In the event where a quality issue arises, the OEM in partnership with the contract manufacturer must work together to respond and remediate all quality issues. This is why choosing a manufacturer with an exceptional quality track record and after-sales support is crucial.
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 site(s). Any issues or inspection observations will need to be addressed and resolved expeditiously to avoid product availability disruptions.
Comprehensive regulatory filings and subsequent approvals are critical elements to a successful partnership with a contract manufacturer. Regulatory submissions (510(k) and CE Mark), as well as regulatory services including the Design History File (DHF), technical file, design dossier, product classification/identification, product labeling / IFU, risk assessment, are key elements to selecting a contract manufacturer. Subsequent to manufacturing launch, regulatory reporting remains an ongoing requirement including Complaint handling, Investigation of complaints of adverse events, Medical device MDR & MDV reportable events, and Supplemental/follow-up reporting. Therefore, it is of utmost importance to verify that the contract manufacturer has a thorough, comprehensive QMS and Regulatory Systems in place for successful monitoring and documentation.
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 body regulations.
The manufacturer should have a specialized factory, focusing exclusively in medical device 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 the 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 the 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 that plays a critical role in your company’s bottom line. Contact us to discover how Quasar can become your trusted partner.