MDDI_Medical Device & Diagnostic Industry

MDDI, July 2016

Issue link:

Contents of this Issue


Page 26 of 39

MD + DI MEDICAL DEVICE AND DIAGNOSTIC INDUSTRY July 2016 | 27 standard's broader reach, suppliers and out- sourcing activities now receive far more scrutiny. ISO 13485:2016 places much greater emphasis on supplier selection criteria. The 2003 version required the establishment of supplier standards, but the updated standard focuses on the performance of the supplier and how that performance can ultimately af- fect the quality of the device. As with the rest of the standard, risk management is more broadly applied so supplier performance is also taken into consideration depending on the risk classification of the device and if the device is able to meet applicable regulatory requirements. There are also reevaluation cri- teria, as well as actions taken when require- ments are not met. Production Control. ISO 13485:2016 institutes a number of changes, with more detail than the previous standard, to pro- vide greater control over device production. These changes concern cleanliness of the product, records of servicing activities, and software validation proportionate to the risk associated with the use of the software on product quality. Section 7.5.8 specifically calls out the requirement for unique device iden- tification, and includes a documented pro- cedure for product identification and status during production. The Benefits of ISO 13485:2016 There are many benefits to adopting ISO 13485:2016 associated with the importance placed on medical device safety and perfor- mance. Regardless of where an individual medical device is in its current life cycle, the new standard helps the manufacturer ac- complish the following: ■ Demonstrate compliance with regulatory requirements. ■ Ensure the establishment of globally-har- monized QMS practices. ■ Manage risk effectively throughout the entire supply chain. ■ Improve manufacturing methodologies and efficiencies. ■ Gain a competitive advantage. The impact of an effective QMS and an organization's approach to quality are fre- quently overlooked. Too often, quality is viewed as a burden. However, organizations that embrace quality often enjoy lower costs, fewer recalls, and overall productivity gains. Embracing quality helps achieve compliance, improves operations, and ultimately delivers a competitive advantage. Conclusion Now that ISO 13485:2016 is here, its new pro- visions can help ensure manufacturing and supply chain quality and integrity, mitigate risk, and navigate more stringent regula- tory hurdles. Medical device manufacturers are well advised to take an in-depth look at the new standard and see how it can benefit them. They stand to gain operational and cost benefits, as well as the ability to ensure the quality of their product portfolios and the ultimate safety of the patients who use them. Bart Reitter is the director of life sciences at Santa Barbara, CA-based manufacturing en- terprise resource planning software company QAD Inc. He can be reached at 2 Content Licensing for Every Marketing Strategy Marketing solutions f t for: • Outdoor • Direct Mail • Print Advertising • Tradeshow/POP Displays • Social Media • Radio & Television Logo Licensing | Reprints | Eprints | Plaques Leverage branded content from MD+DI to create a more powerful and sophisticated statement about your product, service, or company in your next marketing campaign. Contact Wright's Media to f nd out more about how we can customize your acknowledgements and recognitions to enhance your marketing strategies. For more information, call Wright's Media at 877.652.5295 or visit our website at

Articles in this issue

Links on this page

Archives of this issue

view archives of MDDI_Medical Device & Diagnostic Industry - MDDI, July 2016