Iso 13485 definition11/15/2022 ![]() ![]() ![]() A certified company by definition has an established and robust risk management approach to product development that prospectively identifies and estimates risk, while using best-practice control and mitigation techniques to eliminate hazards throughout product realization. ISO 13485:2016 certification also reduces risks associated with medical device research and development programs. Certification communicates to potential business partners that the company is a world-class business that has met, and continues to meet, an objective standard of excellence that enhances their competitive advantage in the marketplace. There are many benefits of working with an ISO 13485:2016 compliant company to bring a medical device to market. ISO 13485:2016 certification confirms that a company has a systematized processes for quality assurance, which ensures products are safe for their intended use and can accelerate speed to market within a stringent quality and regulatory framework. Achieving ISO 13485 certification demonstrates that the company has been independently audited to QMS compliance and is seen as a major milestone toward achieving harmonization with U.S. ISO 13485:2016 is the most recent version of international guidelines for medical device Quality Management Systems (QMS) and is recognized by the Global Harmonization Task Force as the gold standard for medical device quality management worldwide. ISO 13485 is generally harmonized with ISO 9001, but is tailored more specifically to the medical device industry and provides universal standards for the design, manufacture, export, and sale of medical devices. Lack of the development of a robust quality management system required for regulatory clearance at time of submission Inadequate design planning and history documentation of the key assumptions and decisions that resulted in design requirements and outputsĭeficient risk identification, analysis, elimination, and mitigation, as well as insufficient documentation of the overall risk management processīeing required to repeat pivotal bench-top and animal studies that were performed on "uncontrolled" product that cannot be confirmed to have met specification However, this approach can lead to multiple problems with achieving later regulatory clearance due to an inadequate quality system and lack of a company-wide understanding of, or commitment to, quality. There is a major difference between having a quality consultant and developing a new device under a fully implemented and active ISO 13485:2016-certified QMS.ĭangers of medical device development outside a robust QMS include increased program cost, delayed speed to market, regulatory failure, and customer dissatisfaction from: Fledgling medical device research and development companies in the early stages of development often attempt a limited arrangement of only having a "quality" consultant or employee, without a fully defined Quality Management System (QMS). ![]()
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