DeviceLab, a medical device design and medical product development firm, is in constant need of reliable, qualified and affordable manufacturers. In recent years, the answer for some medical product developers has been to take manufacturing overseas, where production costs can be much lower than in the United States. But how do you determine if the overseas molding manufacturers are legitimate and reliable? Please see https://www.devicelab.com/services/prototyping-manufacturing.php for additional medical product manufacturing information.
Dac Vu, President of DeviceLab, a contract medical device design and medical product engineering firm, shares his knowledge and expertise about overseas molders. “Frequently, clients inquire about the cost-savings of taking medical product manufacturing overseas. I tell them that while it is tempting to put your production needs with an overseas molder, you should qualify their capabilities first. At DeviceLab, we have found that a good background check is to research their ISO (International Organization for Standardization) certification.”
The ISO certification process is rigorous, expensive, and requires a complete audit of company procedures and documentation. Many companies who claim to be ISO-certified do not have ISO certification at all. A reference check on the ISO certificate can screen out many unqualified vendors or sales offices/agencies pretending to be manufacturers. Additionally, the name on the certificate must match the name on the registration paperwork.
Vu also states: “Another way of checking to see if a company is certified is by using an overseas representative. It’s not as easy as going online and doing an ISO certification check, but this is a very useful part of deciding if a company is qualified to do your molding. An overseas representative can physically visit an overseas company, knock on the door, see the operation up close and personal, and interview company executives. Our representatives have discovered that some overseas manufacturers do not have a legitimate operation and are falsely advertising their capabilities.”
DeviceLab is a contract medical device design and medical product development] firm in Irvine, California. As a full-service company for mechanical engineering, electronics, software, industrial design, prototyping, manufacturing, FDA regulatory consulting and product testing services, its expertise includes User Interface (UI) design, custom and cart development, medical development, industrial design, hospital equipment, and laboratory instrument development. For more information, please visit DeviceLab.