Risk management is a crucial part of any design and development process. There is a series of checks and balances that must be met, and companies must have an established risk management process in place that complies with industry regulations. In the case of the two recent 737 MAX 8 plane crashes, a great deal of time has been spent trying to determine the root cause of the crashes. One notion is that critical components and software failed due to improperly conducted risk analyses early in the design stage.
Qosina’s white paper discusses the criticality of updating your medical device risk analysis throughout the product lifecycle, conducting proper complaint investigation and designing for human factors.
To download this white paper, visit https://www.qosina.com/what-can-the-medical-device-industry-learn-from-the-boeing-737-max-8-crashes.
Founded in 1980, Qosina is a leading global supplier of OEM single-use components to the medical and pharmaceutical industries. Qosina’s philosophy is to address its customers’ need to reduce time to market by providing thousands of stock components. The company’s vast catalog features more than 5,000 products shown in full-scale illustrations on a one-centimeter grid. Qosina offers free samples of most items, low minimum order requirements, just-in-time delivery, modification of existing molds, and new product design and development. Qosina is ISO 13485, ISO 9001, ISO 22301 and ISO 14001 certified, and operates in a 95,000 square-foot facility with an ISO Class 8 Clean Room. To learn about Qosina’s full component offering, which includes the newest products, visit www.qosina.com or call +1 (631) 242-3000. Visit Qosmedix, Qosina’s cosmetics division, at www.qosmedix.com. Qosmedix is a certified global supplier of beauty supplies to the cosmetic, skincare, spa and salon industries.