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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.



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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.



Why Contract Manufacturers Shouldn't Own Your Quality System

FDA: Overview of Device Regulation

European Union Medical Device Regulation (EUMDR)

ISO 13485

FDA 820

Mike Drues

Greenlight Guru



“Companies are looking to outsource more...of what needs to be done in designing, developing, manufacturing, and commercializing medical devices.” - Jon Speer 

“I don’t want companies to do things because regulations say so. I want them to do it because it makes good business sense.” - Jon Speer

“Medical device companies today, regardless of size, farm out a lot of activities to contract manufacturers.” - Mike Drues

“Hiring a contract manufacturer can provide a cost-effective way to develop devices, but you need to be involved in every step of the process.” - Jon Speer



The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

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