This is a podcast episode titled, Who Should Own Your QMS?. The summary for this episode is: Does your medical device company prefer to outsource the responsibility of its quality management system (QMS) to a third-party supplier? Companies need to understand the ramifications of not owning, managing, and maintaining its QMS.
Today’s guest is Mike Drues of Vascular Sciences. In this episode, Jon Speer and Mike discuss reasons why contract manufacturers should or should not own your company’s QMS.
Some of the highlights of the show include:
● There’s an alarming and risky interest for companies to outsource different parts of designing, developing, manufacturing, and commercializing medical devices.
● Executive management needs to be involved with the quality of the company’s products and processes. Or, they’re in violation of complying with regulations.
● The CEO has the responsibility to ensure that the QMS is appropriate, effective, and structured to meet the needs of the business and regulatory requirements.
● New companies with limited resources should bootstrap their QMS, as well as leverage consulting and system resources.
● Pick a manufacturer that aligns with various aspects of your product. After selecting a qualified contract manufacturer, perform ongoing monitoring of them.
● If it's your company's name on the medical device you're bringing to market, then it is ultimately your company that is legally responsible for your quality system. Will you put your business in the hands of a third party and hope they care as much about your company’s compliance as you do?
● A contract manufacturer can be a cost-effective way to develop devices, but a company needs to maintain its own records and sync them with its QMS.
● Understand medical device regulatory requirements, and clearly identify processes and procedures to address them.