Consulting and Safety: Minimizing Risk from the Start


In a highly regulated space like medical device design and manufacturing, safety standards are frequently updated and changed to stay in step with innovation and minimize risk for patients. The reality is: it’s difficult to adopt a new standard from the early stages of development all the way to hospital implementation. There are roadblocks. For ISO 80369 alone, the Food & Drug Administration (FDA) addressed letters to manufacturers and hospitals in 2010 and 2018, and the Global Enteral Device Supplier Association (GEDSA) regularly developed resources for manufacturers in between. The resources, checklists and calls to action are not always enough to get a project moving.

To get your project off the ground quickly and efficiently, you need consulting services that offer a wealth of industry experience and can help you move to the next stage of your timeline. Finding a project partner to cover the research and testing phases of your process is integral to reducing time to market.

Regardless of the size or scope of the project, your design needs to be reviewed for a combination of cost consideration and evidence of adherence to the current safety standards and regulatory updates. Compliance and material documentation, technical data sheets and compatibility information are among the stack of materials needed to advance a project timeline and continue developing. Look for consulting services that provide documentation upfront, so you can identify the most appropriate materials and components for your project. Detailed component drawings and material specifications simplify part implementation and federal compliance processes as well.

Small order samples are the best options for testing and integrating stock parts during early-stage prototyping. Once you select the ideal stock part for your project, you can place a larger order with confidence you made the right decision.

Qosina stays informed about regulatory changes to ensure your questions are answered and products are better serving patients. We all play a role in reducing risk. We recognize the potential barriers engineers face when implementing design changes on the hospital side, and we aim to drive change for you on the back end.

To learn more about the products Qosina offers to address ISO 80369 and product development consulting services, contact us at (631)242-3000.